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Platelet-rich plasma injections show no benefit in knee OA in placebo-controlled trial

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Changed
Mon, 11/29/2021 - 08:52

 

A large randomized, placebo-controlled trial of platelet-rich plasma injections for knee osteoarthritis has found almost no symptomatic or structural benefit from the treatment, giving some clarity to an evidence base that has seen both positive and negative trials for the treatment modality.

Dr. Kim Bennell

Given the need for better disease-modifying treatments for osteoarthritis, there has been a lot of interest in biological therapies such as platelet-rich plasma and stem cells, the lead author of the study, Kim Bennell, PhD, told this news organization. “People have started to use it to treat osteoarthritis, but the evidence to support it was limited in terms of its quality, and there’s been very little work looking at effects on structure,” said Dr. Bennell, a research physiotherapist and chair of physiotherapy at the University of Melbourne.

Platelet-rich plasma contains a range of growth factors and cytokines that are thought to be beneficial in building cartilage and reducing inflammation. There have been several clinical trials of the treatment in knee osteoarthritis, but the current study’s authors said these were limited by factors such as a lack of blinding and were at high risk of bias. “That was the impetus to do a large, high-quality study and to look at joint structure,” Dr. Bennell said.

Study details

For the study, which was published Nov. 23 in JAMA, the researchers enrolled 288 adults older than 50 with knee osteoarthritis who had experienced knee pain on most days of the past month and had radiographic evidence of mild to moderate osteoarthritis of the tibiofemoral joint.

After having stopped all nonsteroidal anti-inflammatory and pain-relief drugs 2 weeks prior – except acetaminophen – participants were randomly assigned to receive three weekly intra-articular knee injections of either a commercially available leukocyte-poor platelet-rich plasma or saline placebo. They were then followed for 12 months.

Among the 288 participants in the study, researchers saw no statistically significant difference in the change in pain scores between the treatment and placebo groups at 12 months, although there was a nonsignificantly greater reduction in pain scores among those given platelet-rich plasma. The study also found no statistically significant difference between the two groups in the change in medial tibial cartilage volume.

The researchers also looked at a large number of secondary outcomes, including the effects of treatment on pain and function at 2 months, change in Knee Injury and Osteoarthritis Outcome (KOOS) scores, and change in quality of life scores. There were no indications of any benefits from the treatment at the 2-month follow-up, and at 12 months, the study showed no significant improvements in knee pain while walking or in pain scores, KOOS scores, or quality of life measures.

However, significantly more participants in the treatment group than in the placebo group reported overall improvement at the 2-month point – 48.2% of those in the treatment arm, compared with 36.2% of the placebo group (risk ratio, 1.37; 95% confidence interval, 1.05-1.80; P = .02). At 12 months, 42.8% of those who received platelet-rich plasma reported improved function, compared with 32.1% of those in the placebo group (risk ratio, 1.36; 95% CI, 1.00-1.86, P = .05).

The study also found that significantly more people in the platelet-rich plasma group had three or more areas of cartilage thinning at 12 months (17.1% vs. 6.8%; risk ratio, 2.71; 95% CI, 1.16-6.34; P = .02).

Even when researchers looked for treatment effects in subgroups – for example, based on disease severity, body mass index, or knee alignment – they found no significant differences from placebo.

Dr. Bennell said the results were disappointing but not surprising. “Anecdotally, people do report that they get better, but we know that there is a very large placebo effect with treatment of pain,” she said.

 

 

Results emphasize importance of placebo controls

In an accompanying editorial by Jeffrey N. Katz, MD, director of the Orthopaedic and Arthritis Center for Outcomes Research at Brigham and Women’s Hospital, professor of medicine and orthopedic surgery at Harvard Medical School, and professor of epidemiology and environmental health at the Harvard T.H. Chan School of Public Health, all in Boston, draws parallels between this study and two earlier studies of platelet-rich plasma for ankle osteoarthritis and Achilles tendinopathy, both published in JAMA in 2021. None of the three studies showed any significant improvements over and above placebo.

Dr. Jeffrey N. Katz

“These findings emphasize the importance of comparing interventions with placebos in trials of injection therapies,” Dr. Katz writes. However, he notes that these studies do suggest possible benefits in secondary outcomes, such as self-reported pain and function, and that earlier studies of the treatment had had more positive outcomes.



Dr. Katz said it was premature to dismiss platelet-rich plasma as a treatment for knee osteoarthritis, but “until a new generation of trials using standardized approaches to PRP [platelet-rich plasma] therapy provides evidence of efficacy, it would be prudent to pause the use of PRP for OA and Achilles tendinitis.”

Not ready to stop using platelet-rich plasma?

When asked for comment, sports medicine physician Maarten Moen, MD, from the Bergman Clinics Naarden (the Netherlands) said the study was the largest yet of the use of platelet-rich plasma for knee osteoarthritis and that it was a well-designed, double-blind, placebo-controlled trial.

Dr. Maarten Moen

However, he also pointed out that at least six earlier randomized, placebo-controlled studies of this treatment approach have been conducted, and of those six, all but two found positive benefits for patients. “It’s a very well-performed study, but for me, it would be a bridge too far to say, ‘Now we have this study, let’s stop doing it,’ ” Dr. Moen said.

Dr. Moen said he would like to see what effect this study had on meta-analyses and systematic reviews of the treatment, as that would give the clearest indication of the overall picture of its effectiveness.

Dr. Moen’s own experience of treating patients with platelet-rich plasma also suggested that, among those who do benefit from the treatment, that benefit would most likely show between 2 and 12 months afterward. He said it would have been useful to see outcomes at 3- and 6-month intervals.

“What I tell people is that, on average, around 9 months’ effect is to be expected,” he said.

Dr. Bennell said the research group chose the 12-month follow-up because they wanted to see if there were long-term improvements in joint structure which they hoped for, given the cost of treatment.

The study was funded by the Australian National Health and Medical Research Council, and Regen Lab SA provided platelet-rich plasma kits free of charge. Two authors reported using platelet-rich plasma injections in clinical practice, one reported scientific advisory board fees from Biobone, Novartis, Tissuegene, Pfizer, and Lilly; two reported fees for contributing to UpToDate clinical guidelines, and two reported grants from the National Health and Medical Research Council outside the submitted work. No other conflicts of interest were declared.

A version of this article first appeared on Medscape.com.

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A large randomized, placebo-controlled trial of platelet-rich plasma injections for knee osteoarthritis has found almost no symptomatic or structural benefit from the treatment, giving some clarity to an evidence base that has seen both positive and negative trials for the treatment modality.

Dr. Kim Bennell

Given the need for better disease-modifying treatments for osteoarthritis, there has been a lot of interest in biological therapies such as platelet-rich plasma and stem cells, the lead author of the study, Kim Bennell, PhD, told this news organization. “People have started to use it to treat osteoarthritis, but the evidence to support it was limited in terms of its quality, and there’s been very little work looking at effects on structure,” said Dr. Bennell, a research physiotherapist and chair of physiotherapy at the University of Melbourne.

Platelet-rich plasma contains a range of growth factors and cytokines that are thought to be beneficial in building cartilage and reducing inflammation. There have been several clinical trials of the treatment in knee osteoarthritis, but the current study’s authors said these were limited by factors such as a lack of blinding and were at high risk of bias. “That was the impetus to do a large, high-quality study and to look at joint structure,” Dr. Bennell said.

Study details

For the study, which was published Nov. 23 in JAMA, the researchers enrolled 288 adults older than 50 with knee osteoarthritis who had experienced knee pain on most days of the past month and had radiographic evidence of mild to moderate osteoarthritis of the tibiofemoral joint.

After having stopped all nonsteroidal anti-inflammatory and pain-relief drugs 2 weeks prior – except acetaminophen – participants were randomly assigned to receive three weekly intra-articular knee injections of either a commercially available leukocyte-poor platelet-rich plasma or saline placebo. They were then followed for 12 months.

Among the 288 participants in the study, researchers saw no statistically significant difference in the change in pain scores between the treatment and placebo groups at 12 months, although there was a nonsignificantly greater reduction in pain scores among those given platelet-rich plasma. The study also found no statistically significant difference between the two groups in the change in medial tibial cartilage volume.

The researchers also looked at a large number of secondary outcomes, including the effects of treatment on pain and function at 2 months, change in Knee Injury and Osteoarthritis Outcome (KOOS) scores, and change in quality of life scores. There were no indications of any benefits from the treatment at the 2-month follow-up, and at 12 months, the study showed no significant improvements in knee pain while walking or in pain scores, KOOS scores, or quality of life measures.

However, significantly more participants in the treatment group than in the placebo group reported overall improvement at the 2-month point – 48.2% of those in the treatment arm, compared with 36.2% of the placebo group (risk ratio, 1.37; 95% confidence interval, 1.05-1.80; P = .02). At 12 months, 42.8% of those who received platelet-rich plasma reported improved function, compared with 32.1% of those in the placebo group (risk ratio, 1.36; 95% CI, 1.00-1.86, P = .05).

The study also found that significantly more people in the platelet-rich plasma group had three or more areas of cartilage thinning at 12 months (17.1% vs. 6.8%; risk ratio, 2.71; 95% CI, 1.16-6.34; P = .02).

Even when researchers looked for treatment effects in subgroups – for example, based on disease severity, body mass index, or knee alignment – they found no significant differences from placebo.

Dr. Bennell said the results were disappointing but not surprising. “Anecdotally, people do report that they get better, but we know that there is a very large placebo effect with treatment of pain,” she said.

 

 

Results emphasize importance of placebo controls

In an accompanying editorial by Jeffrey N. Katz, MD, director of the Orthopaedic and Arthritis Center for Outcomes Research at Brigham and Women’s Hospital, professor of medicine and orthopedic surgery at Harvard Medical School, and professor of epidemiology and environmental health at the Harvard T.H. Chan School of Public Health, all in Boston, draws parallels between this study and two earlier studies of platelet-rich plasma for ankle osteoarthritis and Achilles tendinopathy, both published in JAMA in 2021. None of the three studies showed any significant improvements over and above placebo.

Dr. Jeffrey N. Katz

“These findings emphasize the importance of comparing interventions with placebos in trials of injection therapies,” Dr. Katz writes. However, he notes that these studies do suggest possible benefits in secondary outcomes, such as self-reported pain and function, and that earlier studies of the treatment had had more positive outcomes.



Dr. Katz said it was premature to dismiss platelet-rich plasma as a treatment for knee osteoarthritis, but “until a new generation of trials using standardized approaches to PRP [platelet-rich plasma] therapy provides evidence of efficacy, it would be prudent to pause the use of PRP for OA and Achilles tendinitis.”

Not ready to stop using platelet-rich plasma?

When asked for comment, sports medicine physician Maarten Moen, MD, from the Bergman Clinics Naarden (the Netherlands) said the study was the largest yet of the use of platelet-rich plasma for knee osteoarthritis and that it was a well-designed, double-blind, placebo-controlled trial.

Dr. Maarten Moen

However, he also pointed out that at least six earlier randomized, placebo-controlled studies of this treatment approach have been conducted, and of those six, all but two found positive benefits for patients. “It’s a very well-performed study, but for me, it would be a bridge too far to say, ‘Now we have this study, let’s stop doing it,’ ” Dr. Moen said.

Dr. Moen said he would like to see what effect this study had on meta-analyses and systematic reviews of the treatment, as that would give the clearest indication of the overall picture of its effectiveness.

Dr. Moen’s own experience of treating patients with platelet-rich plasma also suggested that, among those who do benefit from the treatment, that benefit would most likely show between 2 and 12 months afterward. He said it would have been useful to see outcomes at 3- and 6-month intervals.

“What I tell people is that, on average, around 9 months’ effect is to be expected,” he said.

Dr. Bennell said the research group chose the 12-month follow-up because they wanted to see if there were long-term improvements in joint structure which they hoped for, given the cost of treatment.

The study was funded by the Australian National Health and Medical Research Council, and Regen Lab SA provided platelet-rich plasma kits free of charge. Two authors reported using platelet-rich plasma injections in clinical practice, one reported scientific advisory board fees from Biobone, Novartis, Tissuegene, Pfizer, and Lilly; two reported fees for contributing to UpToDate clinical guidelines, and two reported grants from the National Health and Medical Research Council outside the submitted work. No other conflicts of interest were declared.

A version of this article first appeared on Medscape.com.

 

A large randomized, placebo-controlled trial of platelet-rich plasma injections for knee osteoarthritis has found almost no symptomatic or structural benefit from the treatment, giving some clarity to an evidence base that has seen both positive and negative trials for the treatment modality.

Dr. Kim Bennell

Given the need for better disease-modifying treatments for osteoarthritis, there has been a lot of interest in biological therapies such as platelet-rich plasma and stem cells, the lead author of the study, Kim Bennell, PhD, told this news organization. “People have started to use it to treat osteoarthritis, but the evidence to support it was limited in terms of its quality, and there’s been very little work looking at effects on structure,” said Dr. Bennell, a research physiotherapist and chair of physiotherapy at the University of Melbourne.

Platelet-rich plasma contains a range of growth factors and cytokines that are thought to be beneficial in building cartilage and reducing inflammation. There have been several clinical trials of the treatment in knee osteoarthritis, but the current study’s authors said these were limited by factors such as a lack of blinding and were at high risk of bias. “That was the impetus to do a large, high-quality study and to look at joint structure,” Dr. Bennell said.

Study details

For the study, which was published Nov. 23 in JAMA, the researchers enrolled 288 adults older than 50 with knee osteoarthritis who had experienced knee pain on most days of the past month and had radiographic evidence of mild to moderate osteoarthritis of the tibiofemoral joint.

After having stopped all nonsteroidal anti-inflammatory and pain-relief drugs 2 weeks prior – except acetaminophen – participants were randomly assigned to receive three weekly intra-articular knee injections of either a commercially available leukocyte-poor platelet-rich plasma or saline placebo. They were then followed for 12 months.

Among the 288 participants in the study, researchers saw no statistically significant difference in the change in pain scores between the treatment and placebo groups at 12 months, although there was a nonsignificantly greater reduction in pain scores among those given platelet-rich plasma. The study also found no statistically significant difference between the two groups in the change in medial tibial cartilage volume.

The researchers also looked at a large number of secondary outcomes, including the effects of treatment on pain and function at 2 months, change in Knee Injury and Osteoarthritis Outcome (KOOS) scores, and change in quality of life scores. There were no indications of any benefits from the treatment at the 2-month follow-up, and at 12 months, the study showed no significant improvements in knee pain while walking or in pain scores, KOOS scores, or quality of life measures.

However, significantly more participants in the treatment group than in the placebo group reported overall improvement at the 2-month point – 48.2% of those in the treatment arm, compared with 36.2% of the placebo group (risk ratio, 1.37; 95% confidence interval, 1.05-1.80; P = .02). At 12 months, 42.8% of those who received platelet-rich plasma reported improved function, compared with 32.1% of those in the placebo group (risk ratio, 1.36; 95% CI, 1.00-1.86, P = .05).

The study also found that significantly more people in the platelet-rich plasma group had three or more areas of cartilage thinning at 12 months (17.1% vs. 6.8%; risk ratio, 2.71; 95% CI, 1.16-6.34; P = .02).

Even when researchers looked for treatment effects in subgroups – for example, based on disease severity, body mass index, or knee alignment – they found no significant differences from placebo.

Dr. Bennell said the results were disappointing but not surprising. “Anecdotally, people do report that they get better, but we know that there is a very large placebo effect with treatment of pain,” she said.

 

 

Results emphasize importance of placebo controls

In an accompanying editorial by Jeffrey N. Katz, MD, director of the Orthopaedic and Arthritis Center for Outcomes Research at Brigham and Women’s Hospital, professor of medicine and orthopedic surgery at Harvard Medical School, and professor of epidemiology and environmental health at the Harvard T.H. Chan School of Public Health, all in Boston, draws parallels between this study and two earlier studies of platelet-rich plasma for ankle osteoarthritis and Achilles tendinopathy, both published in JAMA in 2021. None of the three studies showed any significant improvements over and above placebo.

Dr. Jeffrey N. Katz

“These findings emphasize the importance of comparing interventions with placebos in trials of injection therapies,” Dr. Katz writes. However, he notes that these studies do suggest possible benefits in secondary outcomes, such as self-reported pain and function, and that earlier studies of the treatment had had more positive outcomes.



Dr. Katz said it was premature to dismiss platelet-rich plasma as a treatment for knee osteoarthritis, but “until a new generation of trials using standardized approaches to PRP [platelet-rich plasma] therapy provides evidence of efficacy, it would be prudent to pause the use of PRP for OA and Achilles tendinitis.”

Not ready to stop using platelet-rich plasma?

When asked for comment, sports medicine physician Maarten Moen, MD, from the Bergman Clinics Naarden (the Netherlands) said the study was the largest yet of the use of platelet-rich plasma for knee osteoarthritis and that it was a well-designed, double-blind, placebo-controlled trial.

Dr. Maarten Moen

However, he also pointed out that at least six earlier randomized, placebo-controlled studies of this treatment approach have been conducted, and of those six, all but two found positive benefits for patients. “It’s a very well-performed study, but for me, it would be a bridge too far to say, ‘Now we have this study, let’s stop doing it,’ ” Dr. Moen said.

Dr. Moen said he would like to see what effect this study had on meta-analyses and systematic reviews of the treatment, as that would give the clearest indication of the overall picture of its effectiveness.

Dr. Moen’s own experience of treating patients with platelet-rich plasma also suggested that, among those who do benefit from the treatment, that benefit would most likely show between 2 and 12 months afterward. He said it would have been useful to see outcomes at 3- and 6-month intervals.

“What I tell people is that, on average, around 9 months’ effect is to be expected,” he said.

Dr. Bennell said the research group chose the 12-month follow-up because they wanted to see if there were long-term improvements in joint structure which they hoped for, given the cost of treatment.

The study was funded by the Australian National Health and Medical Research Council, and Regen Lab SA provided platelet-rich plasma kits free of charge. Two authors reported using platelet-rich plasma injections in clinical practice, one reported scientific advisory board fees from Biobone, Novartis, Tissuegene, Pfizer, and Lilly; two reported fees for contributing to UpToDate clinical guidelines, and two reported grants from the National Health and Medical Research Council outside the submitted work. No other conflicts of interest were declared.

A version of this article first appeared on Medscape.com.

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PT may lower risk of long-term opioid use after knee replacement

Article Type
Changed
Mon, 11/01/2021 - 16:42

A new study has found that physical therapy may lead to a reduced risk of long-term opioid use in patients who have undergone total knee replacement (TKR).

ChooChin/Getty Images

“Greater number of PT intervention sessions and earlier initiation of outpatient PT care after TKR were associated with lower odds of long-term opioid use,” authors from Boston University wrote in their report on the study, which was published online Oct. 27 in JAMA Network Open.

“In previous large studies, we’ve seen that physical therapy can reduce pain in people with knee osteoarthritis, which is usually the primary indication for TKR,” study coauthor Deepak Kumar, PT, PhD, said in an interview. “But the association of physical therapy with opioid use in people with knee replacement has not yet been explored.

Dr. Deepak Kumar

“The reason we focused on opioid use in these patients is because the number of knee replacement surgeries is going up exponentially,” Dr. Kumar said. “And, depending on which data you look at, from one-third to up to half of people who undergo knee replacement and have used opioids before end up becoming long-term users. Even in people who have not used them before, 5%-8% become long-term users after the surgery.

“Given how many surgeries are happening – and that number is expected to keep going up – the number of people who are becoming long-term opioid users is not trivial,” he said.
 

Study details

To assess the value of PT in reducing opioid use in this subset of patients, the authors reviewed records from the OptumLabs Data Warehouse insurance claims database to identify 67,322 eligible participants aged 40 or older who underwent TKR from Jan. 1, 2001, to Dec. 31, 2016. Of those patients, 38,408 were opioid naive and 28,914 had taken opioids before. The authors evaluated long-term opioid use – defined as 90 days or more of filled prescriptions – during a 12-month outcome assessment period that varied depending on differences in post-TKR PT start date and duration.

The researchers found a significantly lower likelihood of long-term opioid use associated with receipt of any PT before TKR among patients who had not taken opioids before (adjusted odds ratio [aOR], 0.75; 95% confidence interval, 0.60-0.95) and those who had taken opioids in the past (aOR, 0.75; 95% CI, 0.70-0.80).

Investigators found that 2.2% of participants in the opioid-naive group and 32.5% of those in the opioid-experienced group used opioids long-term after TKR. Approximately 76% of participants overall received outpatient PT within the 90 days after surgery, and the receipt of post-TKR PT at any point was associated with lower odds of long-term opioid use in the opioid-experienced group (aOR, 0.75; 95% CI, 0.70-0.79).

Among the opioid-experienced group, receiving between 6 and 12 PT sessions (aOR, 0.82; 95% CI, 0.75-0.90) or ≥ 13 sessions (aOR, 0.71; 95% CI, 0.65-0.77) were both associated with lower odds of long-term opioid use, compared with those who received 1-5 sessions. Beginning PT 31-60 days or 61-90 days after surgery was associated with greater odds of long-term opioid use across both cohorts, compared with those who initiated therapy within 30 days of TKR.
 

 

 

Physical therapy: Underexplored option for pain in knee replacement

One finding caught the researchers slightly off guard: There was no association between active physical therapy and reduced odds of long-term opioid use. “From prior studies, at least in people with knee osteoarthritis, we know that active interventions were more useful than passive interventions,” Dr. Kumar said.

That said, he added that there is still some professional uncertainty regarding “the right type or the right components of physical therapy for managing pain in this population.” Regardless, he believes their study emphasizes the benefits of PT as a pain alleviator in these patients, especially those who have previously used opioids.

“Pharmaceuticals have side effects. Injections are not super effective,” he said. “The idea behind focusing on physical therapy interventions is that it’s widely available, it does you no harm, and it could potentially be lower cost to both the payers and the providers.”



The authors acknowledged their study’s limitations, including not adjusting for opioid use within the 90 days after surgery as well as the different outcome assessment periods for pre-TKR and post-TKR PT exposures. In addition, they admitted that some of the patients who received PT could have been among those less likely to be treated with opioids, and vice versa. “A randomized clinical trial,” they wrote, “would be required to disentangle these issues.”

The study was supported by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kumar reported receiving grants from the National Institutes of Health during the conduct of the study and grants from Pfizer for unrelated projects outside the submitted work. The full list of author disclosures can be found with the original article.

A version of this article first appeared on Medscape.com.

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A new study has found that physical therapy may lead to a reduced risk of long-term opioid use in patients who have undergone total knee replacement (TKR).

ChooChin/Getty Images

“Greater number of PT intervention sessions and earlier initiation of outpatient PT care after TKR were associated with lower odds of long-term opioid use,” authors from Boston University wrote in their report on the study, which was published online Oct. 27 in JAMA Network Open.

“In previous large studies, we’ve seen that physical therapy can reduce pain in people with knee osteoarthritis, which is usually the primary indication for TKR,” study coauthor Deepak Kumar, PT, PhD, said in an interview. “But the association of physical therapy with opioid use in people with knee replacement has not yet been explored.

Dr. Deepak Kumar

“The reason we focused on opioid use in these patients is because the number of knee replacement surgeries is going up exponentially,” Dr. Kumar said. “And, depending on which data you look at, from one-third to up to half of people who undergo knee replacement and have used opioids before end up becoming long-term users. Even in people who have not used them before, 5%-8% become long-term users after the surgery.

“Given how many surgeries are happening – and that number is expected to keep going up – the number of people who are becoming long-term opioid users is not trivial,” he said.
 

Study details

To assess the value of PT in reducing opioid use in this subset of patients, the authors reviewed records from the OptumLabs Data Warehouse insurance claims database to identify 67,322 eligible participants aged 40 or older who underwent TKR from Jan. 1, 2001, to Dec. 31, 2016. Of those patients, 38,408 were opioid naive and 28,914 had taken opioids before. The authors evaluated long-term opioid use – defined as 90 days or more of filled prescriptions – during a 12-month outcome assessment period that varied depending on differences in post-TKR PT start date and duration.

The researchers found a significantly lower likelihood of long-term opioid use associated with receipt of any PT before TKR among patients who had not taken opioids before (adjusted odds ratio [aOR], 0.75; 95% confidence interval, 0.60-0.95) and those who had taken opioids in the past (aOR, 0.75; 95% CI, 0.70-0.80).

Investigators found that 2.2% of participants in the opioid-naive group and 32.5% of those in the opioid-experienced group used opioids long-term after TKR. Approximately 76% of participants overall received outpatient PT within the 90 days after surgery, and the receipt of post-TKR PT at any point was associated with lower odds of long-term opioid use in the opioid-experienced group (aOR, 0.75; 95% CI, 0.70-0.79).

Among the opioid-experienced group, receiving between 6 and 12 PT sessions (aOR, 0.82; 95% CI, 0.75-0.90) or ≥ 13 sessions (aOR, 0.71; 95% CI, 0.65-0.77) were both associated with lower odds of long-term opioid use, compared with those who received 1-5 sessions. Beginning PT 31-60 days or 61-90 days after surgery was associated with greater odds of long-term opioid use across both cohorts, compared with those who initiated therapy within 30 days of TKR.
 

 

 

Physical therapy: Underexplored option for pain in knee replacement

One finding caught the researchers slightly off guard: There was no association between active physical therapy and reduced odds of long-term opioid use. “From prior studies, at least in people with knee osteoarthritis, we know that active interventions were more useful than passive interventions,” Dr. Kumar said.

That said, he added that there is still some professional uncertainty regarding “the right type or the right components of physical therapy for managing pain in this population.” Regardless, he believes their study emphasizes the benefits of PT as a pain alleviator in these patients, especially those who have previously used opioids.

“Pharmaceuticals have side effects. Injections are not super effective,” he said. “The idea behind focusing on physical therapy interventions is that it’s widely available, it does you no harm, and it could potentially be lower cost to both the payers and the providers.”



The authors acknowledged their study’s limitations, including not adjusting for opioid use within the 90 days after surgery as well as the different outcome assessment periods for pre-TKR and post-TKR PT exposures. In addition, they admitted that some of the patients who received PT could have been among those less likely to be treated with opioids, and vice versa. “A randomized clinical trial,” they wrote, “would be required to disentangle these issues.”

The study was supported by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kumar reported receiving grants from the National Institutes of Health during the conduct of the study and grants from Pfizer for unrelated projects outside the submitted work. The full list of author disclosures can be found with the original article.

A version of this article first appeared on Medscape.com.

A new study has found that physical therapy may lead to a reduced risk of long-term opioid use in patients who have undergone total knee replacement (TKR).

ChooChin/Getty Images

“Greater number of PT intervention sessions and earlier initiation of outpatient PT care after TKR were associated with lower odds of long-term opioid use,” authors from Boston University wrote in their report on the study, which was published online Oct. 27 in JAMA Network Open.

“In previous large studies, we’ve seen that physical therapy can reduce pain in people with knee osteoarthritis, which is usually the primary indication for TKR,” study coauthor Deepak Kumar, PT, PhD, said in an interview. “But the association of physical therapy with opioid use in people with knee replacement has not yet been explored.

Dr. Deepak Kumar

“The reason we focused on opioid use in these patients is because the number of knee replacement surgeries is going up exponentially,” Dr. Kumar said. “And, depending on which data you look at, from one-third to up to half of people who undergo knee replacement and have used opioids before end up becoming long-term users. Even in people who have not used them before, 5%-8% become long-term users after the surgery.

“Given how many surgeries are happening – and that number is expected to keep going up – the number of people who are becoming long-term opioid users is not trivial,” he said.
 

Study details

To assess the value of PT in reducing opioid use in this subset of patients, the authors reviewed records from the OptumLabs Data Warehouse insurance claims database to identify 67,322 eligible participants aged 40 or older who underwent TKR from Jan. 1, 2001, to Dec. 31, 2016. Of those patients, 38,408 were opioid naive and 28,914 had taken opioids before. The authors evaluated long-term opioid use – defined as 90 days or more of filled prescriptions – during a 12-month outcome assessment period that varied depending on differences in post-TKR PT start date and duration.

The researchers found a significantly lower likelihood of long-term opioid use associated with receipt of any PT before TKR among patients who had not taken opioids before (adjusted odds ratio [aOR], 0.75; 95% confidence interval, 0.60-0.95) and those who had taken opioids in the past (aOR, 0.75; 95% CI, 0.70-0.80).

Investigators found that 2.2% of participants in the opioid-naive group and 32.5% of those in the opioid-experienced group used opioids long-term after TKR. Approximately 76% of participants overall received outpatient PT within the 90 days after surgery, and the receipt of post-TKR PT at any point was associated with lower odds of long-term opioid use in the opioid-experienced group (aOR, 0.75; 95% CI, 0.70-0.79).

Among the opioid-experienced group, receiving between 6 and 12 PT sessions (aOR, 0.82; 95% CI, 0.75-0.90) or ≥ 13 sessions (aOR, 0.71; 95% CI, 0.65-0.77) were both associated with lower odds of long-term opioid use, compared with those who received 1-5 sessions. Beginning PT 31-60 days or 61-90 days after surgery was associated with greater odds of long-term opioid use across both cohorts, compared with those who initiated therapy within 30 days of TKR.
 

 

 

Physical therapy: Underexplored option for pain in knee replacement

One finding caught the researchers slightly off guard: There was no association between active physical therapy and reduced odds of long-term opioid use. “From prior studies, at least in people with knee osteoarthritis, we know that active interventions were more useful than passive interventions,” Dr. Kumar said.

That said, he added that there is still some professional uncertainty regarding “the right type or the right components of physical therapy for managing pain in this population.” Regardless, he believes their study emphasizes the benefits of PT as a pain alleviator in these patients, especially those who have previously used opioids.

“Pharmaceuticals have side effects. Injections are not super effective,” he said. “The idea behind focusing on physical therapy interventions is that it’s widely available, it does you no harm, and it could potentially be lower cost to both the payers and the providers.”



The authors acknowledged their study’s limitations, including not adjusting for opioid use within the 90 days after surgery as well as the different outcome assessment periods for pre-TKR and post-TKR PT exposures. In addition, they admitted that some of the patients who received PT could have been among those less likely to be treated with opioids, and vice versa. “A randomized clinical trial,” they wrote, “would be required to disentangle these issues.”

The study was supported by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kumar reported receiving grants from the National Institutes of Health during the conduct of the study and grants from Pfizer for unrelated projects outside the submitted work. The full list of author disclosures can be found with the original article.

A version of this article first appeared on Medscape.com.

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PRP injections don’t top placebo for ankle osteoarthritis

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Tue, 10/26/2021 - 15:05

Platelet-rich plasma (PRP) injections did not significantly improve pain or function when compared with placebo injections in patients with ankle osteoarthritis (OA), a new study has found.

“Previous evidence for PRP injections in ankle osteoarthritis was limited to 4 small case series with methodological flaws,” wrote Liam D. A. Paget, MD, of the University of Amsterdam, and coauthors. The study was published online Oct. 26 in JAMA.

To assess the value of PRP injections as a treatment for ankle OA, the researchers launched a double-blind, randomized clinical trial of Dutch patients with notable ankle pain and tibiotalar joint space narrowing. From six sites in the Netherlands, 100 patients (45% women, mean age 56 years) were split into two groups: one that received two intra-articular injections of PRP 6 weeks apart (n = 48) and one that received two injections of saline placebo (n = 52).

At baseline, mean American Orthopaedic Foot and Ankle Society (AOFAS) scores were 63 in the PRP group and 64 in the placebo group (range 0-100, with higher scores indicating less pain and more function). At 26-week follow-up, the mean AOFAS score improved by 10 points in the PRP group (95% confidence interval, 6-14; P < .001) and by 11 points in the placebo group (95% CI, 7-15; P < .001). The adjusted between-group difference for AOFAS improvement over 26 weeks was –1 point (95% CI, –6 to 3; P = .56).

There was one serious adverse event in the placebo group – a transient ischemic attack 3 weeks after the first injection – but it was deemed unrelated.
 

Searching for answers regarding PRP and osteoarthritis

“From my standpoint, this study is a great step forward to where the field needs to be, which is honing in on longer-term studies that are standardizing PRP and teasing out its effects,” Prathap Jayaram, MD, director of regenerative sports medicine at the Baylor College of Medicine in Houston, said in an interview.

Dr. Prathap Jayaram

He highlighted the authors’ acknowledgment of previous studies in which PRP injections appeared effective in treating knee OA, including their statement that the “results reported here for ankle osteoarthritis were not consistent with these potentially beneficial effects in knee osteoarthritis.”

“They’re acknowledging that this does have some benefit in knees,” he said. “Could that translate toward the ankle?”

“PRP did lead to an improvement,” he added. “There just wasn’t a big enough difference to say one was superior to the other.”

Citing his team’s recent preclinical study that was published in Osteoarthritis and Cartilage, Dr. Jayaram emphasized the possibility that PRP could have much-needed disease-modifying effects in osteoarthritis. More work is needed to pin down the details.

“We need more mechanistic studies to be done so we can actually identify the therapeutic properties in PRP and leverage them to track reproducible outcomes,” he said, adding that “simply put, your blood and my blood might be different. There is going to be heterogeneity there. The analogy I give my patients is, when they take an antibiotic, we have a specific dose, a specific drug, and a specific duration. It’s very standardized. We’re just not there yet with PRP.”

The authors acknowledged their study’s limitations, including a likely inability to generalize their results to other platelet-rich blood products as well as a lack of composition analysis of the PRP they used. That said, they added that this particular PRP has been “analyzed previously” for another trial and noted that such analysis is not typically performed in a clinical setting.

The study was supported by a grant from the Dutch Arthritis Society. Its authors reported several potential conflicts of interest, including receiving their own grants from the Dutch Arthritis Society and other organizations, as well as accepting loaned Hettich centrifuges from a medical device company for the study.

A version of this article first appeared on Medscape.com.

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Platelet-rich plasma (PRP) injections did not significantly improve pain or function when compared with placebo injections in patients with ankle osteoarthritis (OA), a new study has found.

“Previous evidence for PRP injections in ankle osteoarthritis was limited to 4 small case series with methodological flaws,” wrote Liam D. A. Paget, MD, of the University of Amsterdam, and coauthors. The study was published online Oct. 26 in JAMA.

To assess the value of PRP injections as a treatment for ankle OA, the researchers launched a double-blind, randomized clinical trial of Dutch patients with notable ankle pain and tibiotalar joint space narrowing. From six sites in the Netherlands, 100 patients (45% women, mean age 56 years) were split into two groups: one that received two intra-articular injections of PRP 6 weeks apart (n = 48) and one that received two injections of saline placebo (n = 52).

At baseline, mean American Orthopaedic Foot and Ankle Society (AOFAS) scores were 63 in the PRP group and 64 in the placebo group (range 0-100, with higher scores indicating less pain and more function). At 26-week follow-up, the mean AOFAS score improved by 10 points in the PRP group (95% confidence interval, 6-14; P < .001) and by 11 points in the placebo group (95% CI, 7-15; P < .001). The adjusted between-group difference for AOFAS improvement over 26 weeks was –1 point (95% CI, –6 to 3; P = .56).

There was one serious adverse event in the placebo group – a transient ischemic attack 3 weeks after the first injection – but it was deemed unrelated.
 

Searching for answers regarding PRP and osteoarthritis

“From my standpoint, this study is a great step forward to where the field needs to be, which is honing in on longer-term studies that are standardizing PRP and teasing out its effects,” Prathap Jayaram, MD, director of regenerative sports medicine at the Baylor College of Medicine in Houston, said in an interview.

Dr. Prathap Jayaram

He highlighted the authors’ acknowledgment of previous studies in which PRP injections appeared effective in treating knee OA, including their statement that the “results reported here for ankle osteoarthritis were not consistent with these potentially beneficial effects in knee osteoarthritis.”

“They’re acknowledging that this does have some benefit in knees,” he said. “Could that translate toward the ankle?”

“PRP did lead to an improvement,” he added. “There just wasn’t a big enough difference to say one was superior to the other.”

Citing his team’s recent preclinical study that was published in Osteoarthritis and Cartilage, Dr. Jayaram emphasized the possibility that PRP could have much-needed disease-modifying effects in osteoarthritis. More work is needed to pin down the details.

“We need more mechanistic studies to be done so we can actually identify the therapeutic properties in PRP and leverage them to track reproducible outcomes,” he said, adding that “simply put, your blood and my blood might be different. There is going to be heterogeneity there. The analogy I give my patients is, when they take an antibiotic, we have a specific dose, a specific drug, and a specific duration. It’s very standardized. We’re just not there yet with PRP.”

The authors acknowledged their study’s limitations, including a likely inability to generalize their results to other platelet-rich blood products as well as a lack of composition analysis of the PRP they used. That said, they added that this particular PRP has been “analyzed previously” for another trial and noted that such analysis is not typically performed in a clinical setting.

The study was supported by a grant from the Dutch Arthritis Society. Its authors reported several potential conflicts of interest, including receiving their own grants from the Dutch Arthritis Society and other organizations, as well as accepting loaned Hettich centrifuges from a medical device company for the study.

A version of this article first appeared on Medscape.com.

Platelet-rich plasma (PRP) injections did not significantly improve pain or function when compared with placebo injections in patients with ankle osteoarthritis (OA), a new study has found.

“Previous evidence for PRP injections in ankle osteoarthritis was limited to 4 small case series with methodological flaws,” wrote Liam D. A. Paget, MD, of the University of Amsterdam, and coauthors. The study was published online Oct. 26 in JAMA.

To assess the value of PRP injections as a treatment for ankle OA, the researchers launched a double-blind, randomized clinical trial of Dutch patients with notable ankle pain and tibiotalar joint space narrowing. From six sites in the Netherlands, 100 patients (45% women, mean age 56 years) were split into two groups: one that received two intra-articular injections of PRP 6 weeks apart (n = 48) and one that received two injections of saline placebo (n = 52).

At baseline, mean American Orthopaedic Foot and Ankle Society (AOFAS) scores were 63 in the PRP group and 64 in the placebo group (range 0-100, with higher scores indicating less pain and more function). At 26-week follow-up, the mean AOFAS score improved by 10 points in the PRP group (95% confidence interval, 6-14; P < .001) and by 11 points in the placebo group (95% CI, 7-15; P < .001). The adjusted between-group difference for AOFAS improvement over 26 weeks was –1 point (95% CI, –6 to 3; P = .56).

There was one serious adverse event in the placebo group – a transient ischemic attack 3 weeks after the first injection – but it was deemed unrelated.
 

Searching for answers regarding PRP and osteoarthritis

“From my standpoint, this study is a great step forward to where the field needs to be, which is honing in on longer-term studies that are standardizing PRP and teasing out its effects,” Prathap Jayaram, MD, director of regenerative sports medicine at the Baylor College of Medicine in Houston, said in an interview.

Dr. Prathap Jayaram

He highlighted the authors’ acknowledgment of previous studies in which PRP injections appeared effective in treating knee OA, including their statement that the “results reported here for ankle osteoarthritis were not consistent with these potentially beneficial effects in knee osteoarthritis.”

“They’re acknowledging that this does have some benefit in knees,” he said. “Could that translate toward the ankle?”

“PRP did lead to an improvement,” he added. “There just wasn’t a big enough difference to say one was superior to the other.”

Citing his team’s recent preclinical study that was published in Osteoarthritis and Cartilage, Dr. Jayaram emphasized the possibility that PRP could have much-needed disease-modifying effects in osteoarthritis. More work is needed to pin down the details.

“We need more mechanistic studies to be done so we can actually identify the therapeutic properties in PRP and leverage them to track reproducible outcomes,” he said, adding that “simply put, your blood and my blood might be different. There is going to be heterogeneity there. The analogy I give my patients is, when they take an antibiotic, we have a specific dose, a specific drug, and a specific duration. It’s very standardized. We’re just not there yet with PRP.”

The authors acknowledged their study’s limitations, including a likely inability to generalize their results to other platelet-rich blood products as well as a lack of composition analysis of the PRP they used. That said, they added that this particular PRP has been “analyzed previously” for another trial and noted that such analysis is not typically performed in a clinical setting.

The study was supported by a grant from the Dutch Arthritis Society. Its authors reported several potential conflicts of interest, including receiving their own grants from the Dutch Arthritis Society and other organizations, as well as accepting loaned Hettich centrifuges from a medical device company for the study.

A version of this article first appeared on Medscape.com.

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MDs doing wrong-site surgery: Why is it still happening?

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Changed
Thu, 09/30/2021 - 13:11

In July 2021, University Hospitals, in Cleveland, announced that its staff had transplanted a kidney into the wrong patient. Although the patient who received the kidney was recovering well, the patient who was supposed to have received the kidney was skipped over. As a result of the error, two employees were placed on administrative leave and the incident was being investigated, the hospital announced.

In April 2020, an interventional radiologist at Boca Raton Regional Hospital, in Boca Raton, Fla., was sued for allegedly placing a stent into the wrong kidney of an 80-year-old patient. Using fluoroscopic guidance, the doctor removed an old stent from the right side but incorrectly replaced it with a new stent on the left side, according to an interview conducted by this news organization with the patient’s lawyers at Searcy Law, in West Palm Beach.

Wrong-site surgery -- surgery performed on the wrong patient, the wrong body part, or the wrong side of the body -- is a rare but distressing event and garners much attention when it happens. “The problem is that it is so rare that doctors don’t focus on it,” says Mary R. Kwaan, MD, a colorectal surgeon at UCLA Medical Center, Los Angeles.

A 2006 study in which Kwaan was the lead author concluded that there was one wrong-site surgery for every 112,994 surgeries. Those mistakes can add up. A 2006 study estimated that 25 to 52 wrong-site surgeries were performed each week in the United States.

“Many surgeons don’t think it can happen to them, so they don’t take extra precautions,” says David Mayer, MD, executive director of the MedStar Institute for Quality and Safety, in Washington, DC. “When they make a wrong-site error, usually the first thing they say is, ‘I never thought this would happen to me,’ ” he says.

Wrong-site surgeries are considered sentinel events -- the worst kinds of medical errors. The Sullivan Group, a patient safety consultancy based in Colorado, reports that in 2013, 2.7% of patients who were involved in wrong-site surgeries died and 41% experienced some type of permanent injury. The mean malpractice payment was $127,000.

Some malpractice payments are much higher. In 2013, a Maryland ob.gyn paid a $1.42 million malpractice award for removing the wrong ovary from a woman in 2009. In 2017, a Pennsylvania urologist paid $870,000 for removing the wrong testicle from a man in 2013.
 

Wrong-site surgery often involves experienced surgeons

One might think that wrong-site surgeries usually involve younger or less-experienced surgeons, but that’s not the case; two thirds of the surgeons who perform wrong-site surgeries are in their 40s and 50s, compared with fewer than 25% younger than 40.

In a rather chilling statistic, in a 2013 survey, 12.4% of doctors who were involved in sentinel events in general had claims for more than one event.

These errors are more common in certain specialties. In a study reported in the Journal of Neurology, Neurosurgery and Spine, 25% of orthopedic surgeons reported performing at least one wrong-site surgery during their career.

Within orthopedics, spine surgery is ground zero for wrong-site surgery. “Finding the site in spine surgery can be more difficult than in common left-right orthopedic procedures,” says Joseph A. Bosco III, a New York City orthopedist.

A 2007 study found that 25% of neurosurgeons had performed wrong-site surgeries. In Missouri in 2013, for example, a 53-year-old patient who was scheduled to undergo a left-sided craniotomy bypass allegedly underwent a right-sided craniotomy and was unable to speak after surgery.

Wrong-site surgeries are also performed by general surgeons, urologists, cardiologists, otolaryngologists, and ophthalmologists. A 2021 lawsuit accused a Tampa urologist of removing the patient’s wrong testicle. And a 2019 lawsuit accused a Chicago ophthalmologist of operating on the wrong eye to remove a cyst.
 

 

 

It’s not just the surgeon’s mistake

Mistakes are not only made by the surgeon in the operating room (OR). They can be made by staff when scheduling a surgery, radiologists and pathologists when writing their reports for surgery, and by team members in the OR.

Many people are prone to confusing left and right. A 2020 study found that 14.9% of people had difficulty distinguishing left from right; other studies have shown higher rates. Distractions increase the likelihood of mistakes. In a 2015 study, background noise in a hospital ward made it more difficult for medical students to make left-right judgments.

OR personnel can be confused when patients are turned around. “To operate on the back of someone’s leg, the surgeon may turn the patient from supine to prone, and so left becomes right,” says Samuel C. Seiden, MD, an anesthesiologist in Roseville, Calif., who has studied wrong-site surgery.

Operative site markings that are drawn on the skin can be rubbed off when surgical prep is applied, and markings aren’t usually possible for procedures such as spine surgeries. Surgical draping can make it harder to distinguish the patient’s left and right, and a busy surgeon relying on memory may confuse cases and perform wrong-patient surgery.
 

A push to eliminate wrong-site surgery

In 2004, the Joint Commission, which accredits hospitals and many surgery centers, decided to do something about wrong-site surgery and related surgical errors. It released a universal protocol, which requires hospitals to take three steps to prevent errors: perform preoperative verification that is based on patient care documents; mark the operative site; and take a time-out just before surgery, during which the team should consider whether a mistake is about to be made.

Two years after the Joint Commission published its protocol, Dr. Seiden led a study to determine what effect it had had. The investigators found that wrong-site cases had decreased by only about one third. Preventing wrong-site surgery “turns out to be more complicated to eradicate than anybody thought,” Mark Chassin, MD, president of the Joint Commission, stated a few years later.

Why did the protocol have only a limited effect? Dr. Seiden says that it has been hard to change doctors’ traditional attitudes against standardization. “Some have had an attitude that checklists are for dummies, but that is changing,” he says.

For instance, some surgical teams were not paying attention during time-outs. “The time-out should be like the invocation of the National Anthem,” an orthopedic surgeon from Iowa wrote. “All other activities should stop.”

Even had surgeons followed the universal protocol, about one third of wrong-site surgeries would not have been identified, according to Dr. Kwaan’s study, which was published in the same year as Dr. Seiden’s. As an example, when the wrong kidney was removed at Methodist Hospital, in St. Louis Park, Minn., the hospital said it was following a protocol set by the Minnesota Hospital Association.
 

Redoubling efforts

In 2009, the Joint Commission decided to take another tack. It encouraged hospitals to make root-cause analyses not only of wrong-site surgeries but also of near misses, which are much more plentiful. It used the insights gained to change surgical routines and protocols.

The Safe Surgery Project, a collaboration between the Joint Commission’s Center for Transforming Healthcare and eight hospitals and surgery centers, reduced the number of errors and near misses by 46% in the scheduling area, 63% in pre-op, and 51% in the OR area.

From that project, the center developed the Targeted Solutions Tool, which basically uses the same methodology that the project used. The center told this news organization that 79 healthcare organizations have used the tool and have reduced the number of errors and near misses by 56% in scheduling, 24% in pre-op, and 48% in the OR.

For this approach to work, however, surgical teams must report their errors to the hospital, which had not been done before. A 2008 study by the Office of the Inspector General of the U.S. Department of Health and Human Services found that surgical staff did not report 86% of adverse events to their hospitals. Reasons given included lack of time, fear of punitive action, and skepticism that reporting would do any good.

Unlike some other adverse events, it’s hard to keep wrong-site surgeries secret from patients, because they can usually see the scars from it, but some surgeons invent ways to cover it up from patients, too, Dr. Mayer says. One wrong-side hernia repair was corrected in mid operation. Afterward, the surgeon told the patient that he had found another hernia on the other side and had fixed that one, too.
 

Changing the culture

Reformers argue that wrong-site surgeries can be prevented by changing the culture of the hospital or surgery center. “We have to think of wrong-site surgeries as a failure of the system, not of the individual,” says Ron Savrin, MD, a general surgeon in Chagrin Falls, Ohio, who is a surgery subject matter expert for the Sullivan Group. “It should never be only up to one individual to stop an error from occurring.”

Seeing oneself as part of a team can reduce errors. Although other people can introduce errors that make a person look bad, they can also stop the errors that might otherwise have occurred. Punishing individuals for making errors does little good in stopping errors.

“It’s human nature to want to punish somebody for making a mistake, and it’s hard to change that mentality,” Dr. Savrin says. He recalls that when he was a resident, “the morbidity and mortality conferences could be very difficult for anyone who made a mistake, but I think that attitude is changing.”

Studies have found wide variation in the number of wrong-site surgeries among hospitals. A recent Pennsylvania study found an average of one wrong-site surgery or near miss per hospital per year, but about one third of hospitals did not report any.

Wrong-site surgeries are often concentrated in certain hospitals -- even prestigious teaching hospitals are not immune. A decade ago, Rhode Island Hospital had five wrong-site surgeries in 2 years, and Boston’s Beth Israel Deaconess Medical Center had three wrong-spine surgeries within 2 months.
 

Other ways to reduce errors

Dr. Seiden thinks reform efforts should take a page from his own specialty. Anesthesiology has developed a variety of forcing functions, which are simple changes in technology that can stop errors. An example is the use of a valve that will not deliver a drug unless certain steps are followed.

The StartBox System, a new way to prevent surgical errors, delivers the surgery blade only after all safety information has been provided. Tested by 11 orthopedic surgeons performing 487 procedures, the system identified 17 near misses.

Another approach is to film time-outs so as to enforce compliance with protocols and help with root-cause analyses. NYU-Langone Medical Center, in New York City, not only films the time-out but also grades OR teams on compliance, says Dr. Bosco, who is vice chair of clinical affairs in the department of orthopedic surgery at the hospital.

In addition, more states are requiring hospitals to report adverse events, including wrong-site surgeries. According to the National Academy for State Health Policy, 28 states require the reporting of adverse events. However, only six states identify facilities in public reports; 16 states publish only aggregate data; and five states do not report error data to the public.
 

The goal is zero errors

Are there fewer wrong-site surgeries now? “My sense is that surgeons, hospitals, and surgery centers are taking wrong-site errors more seriously,” Dr. Savrin says.

Because reported information is spotty and no major studies on incidence have been conducted in recent years, “we don’t have a clear idea,” he says, “but my best guess is that the rate is declining.

“Absolute zero preventable errors has to be our goal,” Dr. Savrin says “We might not get there, but we can’t stop trying.”

A version of this article first appeared on Medscape.com.

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In July 2021, University Hospitals, in Cleveland, announced that its staff had transplanted a kidney into the wrong patient. Although the patient who received the kidney was recovering well, the patient who was supposed to have received the kidney was skipped over. As a result of the error, two employees were placed on administrative leave and the incident was being investigated, the hospital announced.

In April 2020, an interventional radiologist at Boca Raton Regional Hospital, in Boca Raton, Fla., was sued for allegedly placing a stent into the wrong kidney of an 80-year-old patient. Using fluoroscopic guidance, the doctor removed an old stent from the right side but incorrectly replaced it with a new stent on the left side, according to an interview conducted by this news organization with the patient’s lawyers at Searcy Law, in West Palm Beach.

Wrong-site surgery -- surgery performed on the wrong patient, the wrong body part, or the wrong side of the body -- is a rare but distressing event and garners much attention when it happens. “The problem is that it is so rare that doctors don’t focus on it,” says Mary R. Kwaan, MD, a colorectal surgeon at UCLA Medical Center, Los Angeles.

A 2006 study in which Kwaan was the lead author concluded that there was one wrong-site surgery for every 112,994 surgeries. Those mistakes can add up. A 2006 study estimated that 25 to 52 wrong-site surgeries were performed each week in the United States.

“Many surgeons don’t think it can happen to them, so they don’t take extra precautions,” says David Mayer, MD, executive director of the MedStar Institute for Quality and Safety, in Washington, DC. “When they make a wrong-site error, usually the first thing they say is, ‘I never thought this would happen to me,’ ” he says.

Wrong-site surgeries are considered sentinel events -- the worst kinds of medical errors. The Sullivan Group, a patient safety consultancy based in Colorado, reports that in 2013, 2.7% of patients who were involved in wrong-site surgeries died and 41% experienced some type of permanent injury. The mean malpractice payment was $127,000.

Some malpractice payments are much higher. In 2013, a Maryland ob.gyn paid a $1.42 million malpractice award for removing the wrong ovary from a woman in 2009. In 2017, a Pennsylvania urologist paid $870,000 for removing the wrong testicle from a man in 2013.
 

Wrong-site surgery often involves experienced surgeons

One might think that wrong-site surgeries usually involve younger or less-experienced surgeons, but that’s not the case; two thirds of the surgeons who perform wrong-site surgeries are in their 40s and 50s, compared with fewer than 25% younger than 40.

In a rather chilling statistic, in a 2013 survey, 12.4% of doctors who were involved in sentinel events in general had claims for more than one event.

These errors are more common in certain specialties. In a study reported in the Journal of Neurology, Neurosurgery and Spine, 25% of orthopedic surgeons reported performing at least one wrong-site surgery during their career.

Within orthopedics, spine surgery is ground zero for wrong-site surgery. “Finding the site in spine surgery can be more difficult than in common left-right orthopedic procedures,” says Joseph A. Bosco III, a New York City orthopedist.

A 2007 study found that 25% of neurosurgeons had performed wrong-site surgeries. In Missouri in 2013, for example, a 53-year-old patient who was scheduled to undergo a left-sided craniotomy bypass allegedly underwent a right-sided craniotomy and was unable to speak after surgery.

Wrong-site surgeries are also performed by general surgeons, urologists, cardiologists, otolaryngologists, and ophthalmologists. A 2021 lawsuit accused a Tampa urologist of removing the patient’s wrong testicle. And a 2019 lawsuit accused a Chicago ophthalmologist of operating on the wrong eye to remove a cyst.
 

 

 

It’s not just the surgeon’s mistake

Mistakes are not only made by the surgeon in the operating room (OR). They can be made by staff when scheduling a surgery, radiologists and pathologists when writing their reports for surgery, and by team members in the OR.

Many people are prone to confusing left and right. A 2020 study found that 14.9% of people had difficulty distinguishing left from right; other studies have shown higher rates. Distractions increase the likelihood of mistakes. In a 2015 study, background noise in a hospital ward made it more difficult for medical students to make left-right judgments.

OR personnel can be confused when patients are turned around. “To operate on the back of someone’s leg, the surgeon may turn the patient from supine to prone, and so left becomes right,” says Samuel C. Seiden, MD, an anesthesiologist in Roseville, Calif., who has studied wrong-site surgery.

Operative site markings that are drawn on the skin can be rubbed off when surgical prep is applied, and markings aren’t usually possible for procedures such as spine surgeries. Surgical draping can make it harder to distinguish the patient’s left and right, and a busy surgeon relying on memory may confuse cases and perform wrong-patient surgery.
 

A push to eliminate wrong-site surgery

In 2004, the Joint Commission, which accredits hospitals and many surgery centers, decided to do something about wrong-site surgery and related surgical errors. It released a universal protocol, which requires hospitals to take three steps to prevent errors: perform preoperative verification that is based on patient care documents; mark the operative site; and take a time-out just before surgery, during which the team should consider whether a mistake is about to be made.

Two years after the Joint Commission published its protocol, Dr. Seiden led a study to determine what effect it had had. The investigators found that wrong-site cases had decreased by only about one third. Preventing wrong-site surgery “turns out to be more complicated to eradicate than anybody thought,” Mark Chassin, MD, president of the Joint Commission, stated a few years later.

Why did the protocol have only a limited effect? Dr. Seiden says that it has been hard to change doctors’ traditional attitudes against standardization. “Some have had an attitude that checklists are for dummies, but that is changing,” he says.

For instance, some surgical teams were not paying attention during time-outs. “The time-out should be like the invocation of the National Anthem,” an orthopedic surgeon from Iowa wrote. “All other activities should stop.”

Even had surgeons followed the universal protocol, about one third of wrong-site surgeries would not have been identified, according to Dr. Kwaan’s study, which was published in the same year as Dr. Seiden’s. As an example, when the wrong kidney was removed at Methodist Hospital, in St. Louis Park, Minn., the hospital said it was following a protocol set by the Minnesota Hospital Association.
 

Redoubling efforts

In 2009, the Joint Commission decided to take another tack. It encouraged hospitals to make root-cause analyses not only of wrong-site surgeries but also of near misses, which are much more plentiful. It used the insights gained to change surgical routines and protocols.

The Safe Surgery Project, a collaboration between the Joint Commission’s Center for Transforming Healthcare and eight hospitals and surgery centers, reduced the number of errors and near misses by 46% in the scheduling area, 63% in pre-op, and 51% in the OR area.

From that project, the center developed the Targeted Solutions Tool, which basically uses the same methodology that the project used. The center told this news organization that 79 healthcare organizations have used the tool and have reduced the number of errors and near misses by 56% in scheduling, 24% in pre-op, and 48% in the OR.

For this approach to work, however, surgical teams must report their errors to the hospital, which had not been done before. A 2008 study by the Office of the Inspector General of the U.S. Department of Health and Human Services found that surgical staff did not report 86% of adverse events to their hospitals. Reasons given included lack of time, fear of punitive action, and skepticism that reporting would do any good.

Unlike some other adverse events, it’s hard to keep wrong-site surgeries secret from patients, because they can usually see the scars from it, but some surgeons invent ways to cover it up from patients, too, Dr. Mayer says. One wrong-side hernia repair was corrected in mid operation. Afterward, the surgeon told the patient that he had found another hernia on the other side and had fixed that one, too.
 

Changing the culture

Reformers argue that wrong-site surgeries can be prevented by changing the culture of the hospital or surgery center. “We have to think of wrong-site surgeries as a failure of the system, not of the individual,” says Ron Savrin, MD, a general surgeon in Chagrin Falls, Ohio, who is a surgery subject matter expert for the Sullivan Group. “It should never be only up to one individual to stop an error from occurring.”

Seeing oneself as part of a team can reduce errors. Although other people can introduce errors that make a person look bad, they can also stop the errors that might otherwise have occurred. Punishing individuals for making errors does little good in stopping errors.

“It’s human nature to want to punish somebody for making a mistake, and it’s hard to change that mentality,” Dr. Savrin says. He recalls that when he was a resident, “the morbidity and mortality conferences could be very difficult for anyone who made a mistake, but I think that attitude is changing.”

Studies have found wide variation in the number of wrong-site surgeries among hospitals. A recent Pennsylvania study found an average of one wrong-site surgery or near miss per hospital per year, but about one third of hospitals did not report any.

Wrong-site surgeries are often concentrated in certain hospitals -- even prestigious teaching hospitals are not immune. A decade ago, Rhode Island Hospital had five wrong-site surgeries in 2 years, and Boston’s Beth Israel Deaconess Medical Center had three wrong-spine surgeries within 2 months.
 

Other ways to reduce errors

Dr. Seiden thinks reform efforts should take a page from his own specialty. Anesthesiology has developed a variety of forcing functions, which are simple changes in technology that can stop errors. An example is the use of a valve that will not deliver a drug unless certain steps are followed.

The StartBox System, a new way to prevent surgical errors, delivers the surgery blade only after all safety information has been provided. Tested by 11 orthopedic surgeons performing 487 procedures, the system identified 17 near misses.

Another approach is to film time-outs so as to enforce compliance with protocols and help with root-cause analyses. NYU-Langone Medical Center, in New York City, not only films the time-out but also grades OR teams on compliance, says Dr. Bosco, who is vice chair of clinical affairs in the department of orthopedic surgery at the hospital.

In addition, more states are requiring hospitals to report adverse events, including wrong-site surgeries. According to the National Academy for State Health Policy, 28 states require the reporting of adverse events. However, only six states identify facilities in public reports; 16 states publish only aggregate data; and five states do not report error data to the public.
 

The goal is zero errors

Are there fewer wrong-site surgeries now? “My sense is that surgeons, hospitals, and surgery centers are taking wrong-site errors more seriously,” Dr. Savrin says.

Because reported information is spotty and no major studies on incidence have been conducted in recent years, “we don’t have a clear idea,” he says, “but my best guess is that the rate is declining.

“Absolute zero preventable errors has to be our goal,” Dr. Savrin says “We might not get there, but we can’t stop trying.”

A version of this article first appeared on Medscape.com.

In July 2021, University Hospitals, in Cleveland, announced that its staff had transplanted a kidney into the wrong patient. Although the patient who received the kidney was recovering well, the patient who was supposed to have received the kidney was skipped over. As a result of the error, two employees were placed on administrative leave and the incident was being investigated, the hospital announced.

In April 2020, an interventional radiologist at Boca Raton Regional Hospital, in Boca Raton, Fla., was sued for allegedly placing a stent into the wrong kidney of an 80-year-old patient. Using fluoroscopic guidance, the doctor removed an old stent from the right side but incorrectly replaced it with a new stent on the left side, according to an interview conducted by this news organization with the patient’s lawyers at Searcy Law, in West Palm Beach.

Wrong-site surgery -- surgery performed on the wrong patient, the wrong body part, or the wrong side of the body -- is a rare but distressing event and garners much attention when it happens. “The problem is that it is so rare that doctors don’t focus on it,” says Mary R. Kwaan, MD, a colorectal surgeon at UCLA Medical Center, Los Angeles.

A 2006 study in which Kwaan was the lead author concluded that there was one wrong-site surgery for every 112,994 surgeries. Those mistakes can add up. A 2006 study estimated that 25 to 52 wrong-site surgeries were performed each week in the United States.

“Many surgeons don’t think it can happen to them, so they don’t take extra precautions,” says David Mayer, MD, executive director of the MedStar Institute for Quality and Safety, in Washington, DC. “When they make a wrong-site error, usually the first thing they say is, ‘I never thought this would happen to me,’ ” he says.

Wrong-site surgeries are considered sentinel events -- the worst kinds of medical errors. The Sullivan Group, a patient safety consultancy based in Colorado, reports that in 2013, 2.7% of patients who were involved in wrong-site surgeries died and 41% experienced some type of permanent injury. The mean malpractice payment was $127,000.

Some malpractice payments are much higher. In 2013, a Maryland ob.gyn paid a $1.42 million malpractice award for removing the wrong ovary from a woman in 2009. In 2017, a Pennsylvania urologist paid $870,000 for removing the wrong testicle from a man in 2013.
 

Wrong-site surgery often involves experienced surgeons

One might think that wrong-site surgeries usually involve younger or less-experienced surgeons, but that’s not the case; two thirds of the surgeons who perform wrong-site surgeries are in their 40s and 50s, compared with fewer than 25% younger than 40.

In a rather chilling statistic, in a 2013 survey, 12.4% of doctors who were involved in sentinel events in general had claims for more than one event.

These errors are more common in certain specialties. In a study reported in the Journal of Neurology, Neurosurgery and Spine, 25% of orthopedic surgeons reported performing at least one wrong-site surgery during their career.

Within orthopedics, spine surgery is ground zero for wrong-site surgery. “Finding the site in spine surgery can be more difficult than in common left-right orthopedic procedures,” says Joseph A. Bosco III, a New York City orthopedist.

A 2007 study found that 25% of neurosurgeons had performed wrong-site surgeries. In Missouri in 2013, for example, a 53-year-old patient who was scheduled to undergo a left-sided craniotomy bypass allegedly underwent a right-sided craniotomy and was unable to speak after surgery.

Wrong-site surgeries are also performed by general surgeons, urologists, cardiologists, otolaryngologists, and ophthalmologists. A 2021 lawsuit accused a Tampa urologist of removing the patient’s wrong testicle. And a 2019 lawsuit accused a Chicago ophthalmologist of operating on the wrong eye to remove a cyst.
 

 

 

It’s not just the surgeon’s mistake

Mistakes are not only made by the surgeon in the operating room (OR). They can be made by staff when scheduling a surgery, radiologists and pathologists when writing their reports for surgery, and by team members in the OR.

Many people are prone to confusing left and right. A 2020 study found that 14.9% of people had difficulty distinguishing left from right; other studies have shown higher rates. Distractions increase the likelihood of mistakes. In a 2015 study, background noise in a hospital ward made it more difficult for medical students to make left-right judgments.

OR personnel can be confused when patients are turned around. “To operate on the back of someone’s leg, the surgeon may turn the patient from supine to prone, and so left becomes right,” says Samuel C. Seiden, MD, an anesthesiologist in Roseville, Calif., who has studied wrong-site surgery.

Operative site markings that are drawn on the skin can be rubbed off when surgical prep is applied, and markings aren’t usually possible for procedures such as spine surgeries. Surgical draping can make it harder to distinguish the patient’s left and right, and a busy surgeon relying on memory may confuse cases and perform wrong-patient surgery.
 

A push to eliminate wrong-site surgery

In 2004, the Joint Commission, which accredits hospitals and many surgery centers, decided to do something about wrong-site surgery and related surgical errors. It released a universal protocol, which requires hospitals to take three steps to prevent errors: perform preoperative verification that is based on patient care documents; mark the operative site; and take a time-out just before surgery, during which the team should consider whether a mistake is about to be made.

Two years after the Joint Commission published its protocol, Dr. Seiden led a study to determine what effect it had had. The investigators found that wrong-site cases had decreased by only about one third. Preventing wrong-site surgery “turns out to be more complicated to eradicate than anybody thought,” Mark Chassin, MD, president of the Joint Commission, stated a few years later.

Why did the protocol have only a limited effect? Dr. Seiden says that it has been hard to change doctors’ traditional attitudes against standardization. “Some have had an attitude that checklists are for dummies, but that is changing,” he says.

For instance, some surgical teams were not paying attention during time-outs. “The time-out should be like the invocation of the National Anthem,” an orthopedic surgeon from Iowa wrote. “All other activities should stop.”

Even had surgeons followed the universal protocol, about one third of wrong-site surgeries would not have been identified, according to Dr. Kwaan’s study, which was published in the same year as Dr. Seiden’s. As an example, when the wrong kidney was removed at Methodist Hospital, in St. Louis Park, Minn., the hospital said it was following a protocol set by the Minnesota Hospital Association.
 

Redoubling efforts

In 2009, the Joint Commission decided to take another tack. It encouraged hospitals to make root-cause analyses not only of wrong-site surgeries but also of near misses, which are much more plentiful. It used the insights gained to change surgical routines and protocols.

The Safe Surgery Project, a collaboration between the Joint Commission’s Center for Transforming Healthcare and eight hospitals and surgery centers, reduced the number of errors and near misses by 46% in the scheduling area, 63% in pre-op, and 51% in the OR area.

From that project, the center developed the Targeted Solutions Tool, which basically uses the same methodology that the project used. The center told this news organization that 79 healthcare organizations have used the tool and have reduced the number of errors and near misses by 56% in scheduling, 24% in pre-op, and 48% in the OR.

For this approach to work, however, surgical teams must report their errors to the hospital, which had not been done before. A 2008 study by the Office of the Inspector General of the U.S. Department of Health and Human Services found that surgical staff did not report 86% of adverse events to their hospitals. Reasons given included lack of time, fear of punitive action, and skepticism that reporting would do any good.

Unlike some other adverse events, it’s hard to keep wrong-site surgeries secret from patients, because they can usually see the scars from it, but some surgeons invent ways to cover it up from patients, too, Dr. Mayer says. One wrong-side hernia repair was corrected in mid operation. Afterward, the surgeon told the patient that he had found another hernia on the other side and had fixed that one, too.
 

Changing the culture

Reformers argue that wrong-site surgeries can be prevented by changing the culture of the hospital or surgery center. “We have to think of wrong-site surgeries as a failure of the system, not of the individual,” says Ron Savrin, MD, a general surgeon in Chagrin Falls, Ohio, who is a surgery subject matter expert for the Sullivan Group. “It should never be only up to one individual to stop an error from occurring.”

Seeing oneself as part of a team can reduce errors. Although other people can introduce errors that make a person look bad, they can also stop the errors that might otherwise have occurred. Punishing individuals for making errors does little good in stopping errors.

“It’s human nature to want to punish somebody for making a mistake, and it’s hard to change that mentality,” Dr. Savrin says. He recalls that when he was a resident, “the morbidity and mortality conferences could be very difficult for anyone who made a mistake, but I think that attitude is changing.”

Studies have found wide variation in the number of wrong-site surgeries among hospitals. A recent Pennsylvania study found an average of one wrong-site surgery or near miss per hospital per year, but about one third of hospitals did not report any.

Wrong-site surgeries are often concentrated in certain hospitals -- even prestigious teaching hospitals are not immune. A decade ago, Rhode Island Hospital had five wrong-site surgeries in 2 years, and Boston’s Beth Israel Deaconess Medical Center had three wrong-spine surgeries within 2 months.
 

Other ways to reduce errors

Dr. Seiden thinks reform efforts should take a page from his own specialty. Anesthesiology has developed a variety of forcing functions, which are simple changes in technology that can stop errors. An example is the use of a valve that will not deliver a drug unless certain steps are followed.

The StartBox System, a new way to prevent surgical errors, delivers the surgery blade only after all safety information has been provided. Tested by 11 orthopedic surgeons performing 487 procedures, the system identified 17 near misses.

Another approach is to film time-outs so as to enforce compliance with protocols and help with root-cause analyses. NYU-Langone Medical Center, in New York City, not only films the time-out but also grades OR teams on compliance, says Dr. Bosco, who is vice chair of clinical affairs in the department of orthopedic surgery at the hospital.

In addition, more states are requiring hospitals to report adverse events, including wrong-site surgeries. According to the National Academy for State Health Policy, 28 states require the reporting of adverse events. However, only six states identify facilities in public reports; 16 states publish only aggregate data; and five states do not report error data to the public.
 

The goal is zero errors

Are there fewer wrong-site surgeries now? “My sense is that surgeons, hospitals, and surgery centers are taking wrong-site errors more seriously,” Dr. Savrin says.

Because reported information is spotty and no major studies on incidence have been conducted in recent years, “we don’t have a clear idea,” he says, “but my best guess is that the rate is declining.

“Absolute zero preventable errors has to be our goal,” Dr. Savrin says “We might not get there, but we can’t stop trying.”

A version of this article first appeared on Medscape.com.

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AAOS updates guidelines for nonoperative knee OA treatment

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Thu, 09/30/2021 - 09:03

After nearly a decade, the American Academy of Orthopaedic Surgeons has updated its guidance on nonoperative treatment for knee osteoarthritis.

Dr. Robert Brophy

The clinical practice guidelines, released Sept. 13, 2021, is the third edition of the orthopedic society’s clinical practice recommendations.

According to Robert Brophy, MD, FAAOS, an orthopedic surgeon at Washington University, St. Louis, and cochair of the AAOS clinical practice guideline work group, the AAOS guidelines are a “living document” that needs periodic updating as new research comes to light.

“The methodology for maintaining the AAOS guidelines aims to update guideline documents at least every 10 years,” Dr. Brophy said in an interview. “Since the last edition was from 2013, it was time to provide an updated guideline on this very important topic that affects such a high percentage of our patients and providers.”

The guidelines work group, composed of 12 medical doctors and 1 physical therapist, evaluated the evidence for 29 areas of treatment.

A rating scale based on available evidence and the strength of related medical studies labeled each treatment area as demonstrating strong, moderate, or limited evidence.

Eight treatment modalities weighed in with strong evidence for or against their use: lateral wedge insoles, topical or oral NSAIDs, exercise (supervised or unsupervised), self-management programs, patient education programs, oral acetaminophen, and oral opioids.

According to Dr. Brophy, many of the recommendations assigned a strong evidence base were similar to the prior edition of the guidelines.
 

Oral medications

NSAIDs and acetaminophen still remain steadfast options for the treatment of knee pain secondary to OA.

decade3d/Thinkstock

The most notable change was that opioids, which have a long history of being used to treat pain, are strongly recommended not to be used for arthritis.

“Reflecting the growing awareness of and emphasis on the opioid epidemic, one of the strongest changes between the current and prior guidelines centers on the use of opioid medications,” Dr. Brophy said. “In the prior guideline, a strong recommendation was made in favor of tramadol with an inconclusive recommendation made regarding other opioid medications. The updated guideline demonstrates clearly the evidence does not support the use of opioid medications – including tramadol – to treat knee osteoarthritis.”

This may require some education for both patients and doctors to buy in that knee pain can be treated adequately with NSAIDs and acetaminophen.

Patients may not understand that anti-inflammatory drugs treat the pain they are experiencing. They may equate an opioid with a “pain pill” and may need education from their doctor that NSAIDs and acetaminophen not only can relieve their pain, but also avoid potential adverse events prior to or after surgery should they progress to knee replacement surgery.

Furthermore, primary care physicians may not be looking at the long-term picture. Solving a short-term pain problem with opioids may limit the medication’s ability to provide pain relief after surgery should a patient develop a tolerance to the medication’s effects.
 

 

 

Recommendations on hip and foot alignment interventions

When it comes to alignment and joint stresses, the knee is sometimes considered the innocent bystander of hip and foot alignment.

Insoles. How the hip and foot align with each can determine the amount of weight that passes through the medial (inner) or lateral (outer) compartment of the knee. To that end, lateral foot insoles have been used in the past for unloading parts of the knee.

Nevertheless, recent evidence has failed to demonstrate a significant benefit for insoles in the setting of OA knee pain, earning the practice a strong recommendation against its use.

High-tibial osteotomy (HTO). The weight-bearing axis of the lower-extremity axis can also be realigned with HTO. The procedure shifts the body’s weight slightly to the opposite side of the knee.



Newer research has led the practice to be downgraded one level in the new guideline, from moderate to limited, despite its widespread use.

It will, however, likely continue to be used as an alternative to total knee replacement in younger patients and to shift weight away from an area of the knee where cartilage is being restored with a concomitant surgical procedure, according to the work group. They noted that additional research studies on the long-term efficacy of the procedure are still needed.

Topical treatments. The guideline authors gave these a strong recommendation. Gels with anti-inflammatory medication have long been available but were prescription only or of considerable cost. Now several affordable over-the-counter options with the same prescription strength can be found in pharmacies and supermarkets.

What makes these medications unique is that they have an NSAID medication in the formulation, which the vast majority of topical treatments found on shelves do not. They also benefit patients who are unable to tolerate oral NSAIDs because of gastrointestinal side effects.

Comparison with 2019 OARSI recommendations

In 2019, the Osteoarthritis Research Society International also published guidelines for the management of OA of the hand, hip, and knee.

Dr. Thomas Trojian

Thomas Trojian, MD, a family medicine physician with expertise in sports medicine in York, Pa., and member of both the AAOS and OARSI recommendation committees, noted that the OARSI guidelines are meant to be practical guidelines of stepwise nonoperative treatment.

He said in an interview that “the OARSI guidelines recommend dietary weight management, education, and land-based [exercise] therapy, next topical NSAIDs, then injection therapy.”

Intra-articular steroids and viscosupplementation injection therapy in the form of hyaluronic acid derivatives continue to be a mainstay of treatment for both groups.

The AAOS group notably gave a moderate strength recommendation for intra-articular steroid injections with the caveat that the effects typically only last for 3 months. They also included newer extended-release steroid injections in the recommendation, stating that the evidence moderately suggests they provide more benefit than traditional short-acting steroid injections.
 

Methodology differs between guidelines

In the areas where the guidelines don’t fully line up, it is important to remember the methodology of each group often drives the guidelines and recommendations.

Dr. Yale Fillingham

According to Yale Fillingham, MD, an orthopedic surgeon in group private practice in the greater Philadelphia area and the other cochair of the AAOS guidelines committee, the biggest difference between the AAOS and OARSI guidelines is that, although the OARSI guidelines are also grounded in the literature, the recommendation level was based on voting among panel members.

“The AAOS methodology requires the recommendation and strength of the recommendation to be dictated primarily by the best available evidence in the literature and much less on the expertise and opinion of the voting panel,” Dr. Fillingham said in an interview.

He pointed out that the AAOS voting panel can alter the guideline by adjusting the strength of the recommendation but noted it was only in very clearly defined situations. Therefore, the differences in methodology between the groups make it difficult to directly compare the two guidelines.

Multiple guidelines do, however, point to the importance of the issue. Dr. Fillingham commented: “The numerous organizations that have produced guidelines on the treatment of knee osteoarthritis are a testament to the widespread and profound impact of knee osteoarthritis on our health care system and society.”

As a member of both recommendation groups, Dr. Trojian finds both guidelines reveal the importance of understanding that knee OA is a chronic illness. “There are ways we can manage knee OA and reduce the morbidity. ... The core skills of motivational interviewing are important. Open-ended questions, affirmation, reflection, and summarizing are needed to help patients find and remove roadblocks to promote lifestyle changes.”

Dr. Brophy, Dr. Trojian, and Dr. Fillingham have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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After nearly a decade, the American Academy of Orthopaedic Surgeons has updated its guidance on nonoperative treatment for knee osteoarthritis.

Dr. Robert Brophy

The clinical practice guidelines, released Sept. 13, 2021, is the third edition of the orthopedic society’s clinical practice recommendations.

According to Robert Brophy, MD, FAAOS, an orthopedic surgeon at Washington University, St. Louis, and cochair of the AAOS clinical practice guideline work group, the AAOS guidelines are a “living document” that needs periodic updating as new research comes to light.

“The methodology for maintaining the AAOS guidelines aims to update guideline documents at least every 10 years,” Dr. Brophy said in an interview. “Since the last edition was from 2013, it was time to provide an updated guideline on this very important topic that affects such a high percentage of our patients and providers.”

The guidelines work group, composed of 12 medical doctors and 1 physical therapist, evaluated the evidence for 29 areas of treatment.

A rating scale based on available evidence and the strength of related medical studies labeled each treatment area as demonstrating strong, moderate, or limited evidence.

Eight treatment modalities weighed in with strong evidence for or against their use: lateral wedge insoles, topical or oral NSAIDs, exercise (supervised or unsupervised), self-management programs, patient education programs, oral acetaminophen, and oral opioids.

According to Dr. Brophy, many of the recommendations assigned a strong evidence base were similar to the prior edition of the guidelines.
 

Oral medications

NSAIDs and acetaminophen still remain steadfast options for the treatment of knee pain secondary to OA.

decade3d/Thinkstock

The most notable change was that opioids, which have a long history of being used to treat pain, are strongly recommended not to be used for arthritis.

“Reflecting the growing awareness of and emphasis on the opioid epidemic, one of the strongest changes between the current and prior guidelines centers on the use of opioid medications,” Dr. Brophy said. “In the prior guideline, a strong recommendation was made in favor of tramadol with an inconclusive recommendation made regarding other opioid medications. The updated guideline demonstrates clearly the evidence does not support the use of opioid medications – including tramadol – to treat knee osteoarthritis.”

This may require some education for both patients and doctors to buy in that knee pain can be treated adequately with NSAIDs and acetaminophen.

Patients may not understand that anti-inflammatory drugs treat the pain they are experiencing. They may equate an opioid with a “pain pill” and may need education from their doctor that NSAIDs and acetaminophen not only can relieve their pain, but also avoid potential adverse events prior to or after surgery should they progress to knee replacement surgery.

Furthermore, primary care physicians may not be looking at the long-term picture. Solving a short-term pain problem with opioids may limit the medication’s ability to provide pain relief after surgery should a patient develop a tolerance to the medication’s effects.
 

 

 

Recommendations on hip and foot alignment interventions

When it comes to alignment and joint stresses, the knee is sometimes considered the innocent bystander of hip and foot alignment.

Insoles. How the hip and foot align with each can determine the amount of weight that passes through the medial (inner) or lateral (outer) compartment of the knee. To that end, lateral foot insoles have been used in the past for unloading parts of the knee.

Nevertheless, recent evidence has failed to demonstrate a significant benefit for insoles in the setting of OA knee pain, earning the practice a strong recommendation against its use.

High-tibial osteotomy (HTO). The weight-bearing axis of the lower-extremity axis can also be realigned with HTO. The procedure shifts the body’s weight slightly to the opposite side of the knee.



Newer research has led the practice to be downgraded one level in the new guideline, from moderate to limited, despite its widespread use.

It will, however, likely continue to be used as an alternative to total knee replacement in younger patients and to shift weight away from an area of the knee where cartilage is being restored with a concomitant surgical procedure, according to the work group. They noted that additional research studies on the long-term efficacy of the procedure are still needed.

Topical treatments. The guideline authors gave these a strong recommendation. Gels with anti-inflammatory medication have long been available but were prescription only or of considerable cost. Now several affordable over-the-counter options with the same prescription strength can be found in pharmacies and supermarkets.

What makes these medications unique is that they have an NSAID medication in the formulation, which the vast majority of topical treatments found on shelves do not. They also benefit patients who are unable to tolerate oral NSAIDs because of gastrointestinal side effects.

Comparison with 2019 OARSI recommendations

In 2019, the Osteoarthritis Research Society International also published guidelines for the management of OA of the hand, hip, and knee.

Dr. Thomas Trojian

Thomas Trojian, MD, a family medicine physician with expertise in sports medicine in York, Pa., and member of both the AAOS and OARSI recommendation committees, noted that the OARSI guidelines are meant to be practical guidelines of stepwise nonoperative treatment.

He said in an interview that “the OARSI guidelines recommend dietary weight management, education, and land-based [exercise] therapy, next topical NSAIDs, then injection therapy.”

Intra-articular steroids and viscosupplementation injection therapy in the form of hyaluronic acid derivatives continue to be a mainstay of treatment for both groups.

The AAOS group notably gave a moderate strength recommendation for intra-articular steroid injections with the caveat that the effects typically only last for 3 months. They also included newer extended-release steroid injections in the recommendation, stating that the evidence moderately suggests they provide more benefit than traditional short-acting steroid injections.
 

Methodology differs between guidelines

In the areas where the guidelines don’t fully line up, it is important to remember the methodology of each group often drives the guidelines and recommendations.

Dr. Yale Fillingham

According to Yale Fillingham, MD, an orthopedic surgeon in group private practice in the greater Philadelphia area and the other cochair of the AAOS guidelines committee, the biggest difference between the AAOS and OARSI guidelines is that, although the OARSI guidelines are also grounded in the literature, the recommendation level was based on voting among panel members.

“The AAOS methodology requires the recommendation and strength of the recommendation to be dictated primarily by the best available evidence in the literature and much less on the expertise and opinion of the voting panel,” Dr. Fillingham said in an interview.

He pointed out that the AAOS voting panel can alter the guideline by adjusting the strength of the recommendation but noted it was only in very clearly defined situations. Therefore, the differences in methodology between the groups make it difficult to directly compare the two guidelines.

Multiple guidelines do, however, point to the importance of the issue. Dr. Fillingham commented: “The numerous organizations that have produced guidelines on the treatment of knee osteoarthritis are a testament to the widespread and profound impact of knee osteoarthritis on our health care system and society.”

As a member of both recommendation groups, Dr. Trojian finds both guidelines reveal the importance of understanding that knee OA is a chronic illness. “There are ways we can manage knee OA and reduce the morbidity. ... The core skills of motivational interviewing are important. Open-ended questions, affirmation, reflection, and summarizing are needed to help patients find and remove roadblocks to promote lifestyle changes.”

Dr. Brophy, Dr. Trojian, and Dr. Fillingham have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

After nearly a decade, the American Academy of Orthopaedic Surgeons has updated its guidance on nonoperative treatment for knee osteoarthritis.

Dr. Robert Brophy

The clinical practice guidelines, released Sept. 13, 2021, is the third edition of the orthopedic society’s clinical practice recommendations.

According to Robert Brophy, MD, FAAOS, an orthopedic surgeon at Washington University, St. Louis, and cochair of the AAOS clinical practice guideline work group, the AAOS guidelines are a “living document” that needs periodic updating as new research comes to light.

“The methodology for maintaining the AAOS guidelines aims to update guideline documents at least every 10 years,” Dr. Brophy said in an interview. “Since the last edition was from 2013, it was time to provide an updated guideline on this very important topic that affects such a high percentage of our patients and providers.”

The guidelines work group, composed of 12 medical doctors and 1 physical therapist, evaluated the evidence for 29 areas of treatment.

A rating scale based on available evidence and the strength of related medical studies labeled each treatment area as demonstrating strong, moderate, or limited evidence.

Eight treatment modalities weighed in with strong evidence for or against their use: lateral wedge insoles, topical or oral NSAIDs, exercise (supervised or unsupervised), self-management programs, patient education programs, oral acetaminophen, and oral opioids.

According to Dr. Brophy, many of the recommendations assigned a strong evidence base were similar to the prior edition of the guidelines.
 

Oral medications

NSAIDs and acetaminophen still remain steadfast options for the treatment of knee pain secondary to OA.

decade3d/Thinkstock

The most notable change was that opioids, which have a long history of being used to treat pain, are strongly recommended not to be used for arthritis.

“Reflecting the growing awareness of and emphasis on the opioid epidemic, one of the strongest changes between the current and prior guidelines centers on the use of opioid medications,” Dr. Brophy said. “In the prior guideline, a strong recommendation was made in favor of tramadol with an inconclusive recommendation made regarding other opioid medications. The updated guideline demonstrates clearly the evidence does not support the use of opioid medications – including tramadol – to treat knee osteoarthritis.”

This may require some education for both patients and doctors to buy in that knee pain can be treated adequately with NSAIDs and acetaminophen.

Patients may not understand that anti-inflammatory drugs treat the pain they are experiencing. They may equate an opioid with a “pain pill” and may need education from their doctor that NSAIDs and acetaminophen not only can relieve their pain, but also avoid potential adverse events prior to or after surgery should they progress to knee replacement surgery.

Furthermore, primary care physicians may not be looking at the long-term picture. Solving a short-term pain problem with opioids may limit the medication’s ability to provide pain relief after surgery should a patient develop a tolerance to the medication’s effects.
 

 

 

Recommendations on hip and foot alignment interventions

When it comes to alignment and joint stresses, the knee is sometimes considered the innocent bystander of hip and foot alignment.

Insoles. How the hip and foot align with each can determine the amount of weight that passes through the medial (inner) or lateral (outer) compartment of the knee. To that end, lateral foot insoles have been used in the past for unloading parts of the knee.

Nevertheless, recent evidence has failed to demonstrate a significant benefit for insoles in the setting of OA knee pain, earning the practice a strong recommendation against its use.

High-tibial osteotomy (HTO). The weight-bearing axis of the lower-extremity axis can also be realigned with HTO. The procedure shifts the body’s weight slightly to the opposite side of the knee.



Newer research has led the practice to be downgraded one level in the new guideline, from moderate to limited, despite its widespread use.

It will, however, likely continue to be used as an alternative to total knee replacement in younger patients and to shift weight away from an area of the knee where cartilage is being restored with a concomitant surgical procedure, according to the work group. They noted that additional research studies on the long-term efficacy of the procedure are still needed.

Topical treatments. The guideline authors gave these a strong recommendation. Gels with anti-inflammatory medication have long been available but were prescription only or of considerable cost. Now several affordable over-the-counter options with the same prescription strength can be found in pharmacies and supermarkets.

What makes these medications unique is that they have an NSAID medication in the formulation, which the vast majority of topical treatments found on shelves do not. They also benefit patients who are unable to tolerate oral NSAIDs because of gastrointestinal side effects.

Comparison with 2019 OARSI recommendations

In 2019, the Osteoarthritis Research Society International also published guidelines for the management of OA of the hand, hip, and knee.

Dr. Thomas Trojian

Thomas Trojian, MD, a family medicine physician with expertise in sports medicine in York, Pa., and member of both the AAOS and OARSI recommendation committees, noted that the OARSI guidelines are meant to be practical guidelines of stepwise nonoperative treatment.

He said in an interview that “the OARSI guidelines recommend dietary weight management, education, and land-based [exercise] therapy, next topical NSAIDs, then injection therapy.”

Intra-articular steroids and viscosupplementation injection therapy in the form of hyaluronic acid derivatives continue to be a mainstay of treatment for both groups.

The AAOS group notably gave a moderate strength recommendation for intra-articular steroid injections with the caveat that the effects typically only last for 3 months. They also included newer extended-release steroid injections in the recommendation, stating that the evidence moderately suggests they provide more benefit than traditional short-acting steroid injections.
 

Methodology differs between guidelines

In the areas where the guidelines don’t fully line up, it is important to remember the methodology of each group often drives the guidelines and recommendations.

Dr. Yale Fillingham

According to Yale Fillingham, MD, an orthopedic surgeon in group private practice in the greater Philadelphia area and the other cochair of the AAOS guidelines committee, the biggest difference between the AAOS and OARSI guidelines is that, although the OARSI guidelines are also grounded in the literature, the recommendation level was based on voting among panel members.

“The AAOS methodology requires the recommendation and strength of the recommendation to be dictated primarily by the best available evidence in the literature and much less on the expertise and opinion of the voting panel,” Dr. Fillingham said in an interview.

He pointed out that the AAOS voting panel can alter the guideline by adjusting the strength of the recommendation but noted it was only in very clearly defined situations. Therefore, the differences in methodology between the groups make it difficult to directly compare the two guidelines.

Multiple guidelines do, however, point to the importance of the issue. Dr. Fillingham commented: “The numerous organizations that have produced guidelines on the treatment of knee osteoarthritis are a testament to the widespread and profound impact of knee osteoarthritis on our health care system and society.”

As a member of both recommendation groups, Dr. Trojian finds both guidelines reveal the importance of understanding that knee OA is a chronic illness. “There are ways we can manage knee OA and reduce the morbidity. ... The core skills of motivational interviewing are important. Open-ended questions, affirmation, reflection, and summarizing are needed to help patients find and remove roadblocks to promote lifestyle changes.”

Dr. Brophy, Dr. Trojian, and Dr. Fillingham have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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‘Lopioid protocol’ – low-dose opioids – proposed for fracture surgery

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Changed
Tue, 09/07/2021 - 09:25

Orthopedic researchers from New York University have proposed standardizing prescribing patterns for patients after fracture surgery so as to include low-dose opioids.

In a paper presented at the annual meeting of the American Academy of Orthopaedic Surgeons, researchers from NYU reported on the implementation of their multimodal strategy, dubbed the “lopioid protocol.”

According to the 2019 National Survey on Drug Use and Health, orthopedic surgeons are the third-highest opioid prescribers in the United States.

Kennneth A. Egol, MD, vice chair of the department of orthopedic surgery at NYU, who is the first author of the study, was motivated to help create the protocol following misconceptions that orthopedic surgeons were helping to fuel the opioid epidemic.

Dr. Egol pointed to the year 1995, when pain became the fifth vital sign after body temperature, pulse rate, respiratory rate, and blood pressure.

Since then, in light of the opioid epidemic, the focus of physicians has shifted away from prescribing strong pain medication and reducing pain scores to zero to instead reducing pain to a manageable level.

Reducing opioid prescriptions can be challenging when patients are prescribed an anti-inflammatory and they subsequently ask their physician for a “pain pill.” Patients sometimes don’t understand that inflammation is what causes pain.

It can also be difficult to convince patients that medications that they can buy over the counter can adequately control their pain, as confirmed in numerous studies.

Multimodal pain therapy aims to reduce the need for opioids by supplementing their use with other oral medications and, at times, long-lasting regional nerve blocks.

Anti-inflammatories act at the site of injury or surgery where inflammation is occurring. Nerves then carry the pain signal to the brain. These signals can be dampened by medications such as gabapentin that act on the nerves themselves. The pain signal is received in the brain, where opioids act by binding to receptors in the brain.

The so-called lopioid protocol does not eliminate opioids completely but rather uses “safer” opioids, such as tramadol, in lieu of stronger narcotics.

The protocol began at NYU on Jan. 1, 2019. It consists in the prescribing of tramadol, meloxicam, gabapentin, and acetaminophen.

The study presented at the AAOS meeting demonstrated statistically significant reductions in visual analogue pain scores at discharge and subsequent medication refills for the 931 patients in the lopioid group, compared with a group of 848 patients who received narcotic prescriptions containing oxycodone from the year prior to the protocol initiation.

Educating patients on the rationale for the prescription combination can help to allay their fears. Dr. Egol thinks it’s important for physicians to explain the dangers of opioids to patients. He said in an interview that he also believes surgeons need to “give [patients] an understanding of why we are pursuing these protocols. They also need to know we will not ignore their pain and concerns.”

Brannon Orton, MD, is an orthopedic surgeon at Confluence Health, in Moses Lake, Wash. He sees a large number of trauma patients and thinks NYU is doing a good job of addressing a difficult problem in orthopedics – especially in the field of trauma.

He said in an interview: “Managing narcotics postoperatively can be challenging due to the fact that many people come into these fractures with a history of narcotic use.” Not only are they used to turning to opioids for pain relief, but they also may have built up a tolerance to them.

Although he hasn’t been using the lopioid protocol specifically, he has been following a multimodal approach regarding the postoperative use of narcotics. Of the study by Dr. Egol and colleagues, he said, “I think their paper presents an effective way of decreasing use of oral narcotics and still adequately managing patients’ pain postoperatively.” Dr. Orton’s own practice utilizes tramadol, acetaminophen, and ibuprofen after fracture surgery.

From Dr. Orton’s perspective, a significant challenge in implementing the lopioid protocol in practice is simply sticking to the plan. “It can become difficult when patients are pressuring staff or physicians for more narcotics. However, I feel that if everybody is on the same page with the plan, then it can be very doable.”

Dr. Egol and NYU try to limit narcotic prescriptions beginning with the patient’s initial visit to the ED. The ED physicians at his institution only “prescribe small amounts of narcotics. Our ED people really limit the amount of opioids prescribed.”

Dr. Egol recommends that all practitioners begin with nonnarcotic medication, even if treating a fracture nonoperatively. “Start low and go higher. I always try to start with NSAIDs and Tylenol,” he said.

Dr. Egol and Dr. Orton reported no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

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Orthopedic researchers from New York University have proposed standardizing prescribing patterns for patients after fracture surgery so as to include low-dose opioids.

In a paper presented at the annual meeting of the American Academy of Orthopaedic Surgeons, researchers from NYU reported on the implementation of their multimodal strategy, dubbed the “lopioid protocol.”

According to the 2019 National Survey on Drug Use and Health, orthopedic surgeons are the third-highest opioid prescribers in the United States.

Kennneth A. Egol, MD, vice chair of the department of orthopedic surgery at NYU, who is the first author of the study, was motivated to help create the protocol following misconceptions that orthopedic surgeons were helping to fuel the opioid epidemic.

Dr. Egol pointed to the year 1995, when pain became the fifth vital sign after body temperature, pulse rate, respiratory rate, and blood pressure.

Since then, in light of the opioid epidemic, the focus of physicians has shifted away from prescribing strong pain medication and reducing pain scores to zero to instead reducing pain to a manageable level.

Reducing opioid prescriptions can be challenging when patients are prescribed an anti-inflammatory and they subsequently ask their physician for a “pain pill.” Patients sometimes don’t understand that inflammation is what causes pain.

It can also be difficult to convince patients that medications that they can buy over the counter can adequately control their pain, as confirmed in numerous studies.

Multimodal pain therapy aims to reduce the need for opioids by supplementing their use with other oral medications and, at times, long-lasting regional nerve blocks.

Anti-inflammatories act at the site of injury or surgery where inflammation is occurring. Nerves then carry the pain signal to the brain. These signals can be dampened by medications such as gabapentin that act on the nerves themselves. The pain signal is received in the brain, where opioids act by binding to receptors in the brain.

The so-called lopioid protocol does not eliminate opioids completely but rather uses “safer” opioids, such as tramadol, in lieu of stronger narcotics.

The protocol began at NYU on Jan. 1, 2019. It consists in the prescribing of tramadol, meloxicam, gabapentin, and acetaminophen.

The study presented at the AAOS meeting demonstrated statistically significant reductions in visual analogue pain scores at discharge and subsequent medication refills for the 931 patients in the lopioid group, compared with a group of 848 patients who received narcotic prescriptions containing oxycodone from the year prior to the protocol initiation.

Educating patients on the rationale for the prescription combination can help to allay their fears. Dr. Egol thinks it’s important for physicians to explain the dangers of opioids to patients. He said in an interview that he also believes surgeons need to “give [patients] an understanding of why we are pursuing these protocols. They also need to know we will not ignore their pain and concerns.”

Brannon Orton, MD, is an orthopedic surgeon at Confluence Health, in Moses Lake, Wash. He sees a large number of trauma patients and thinks NYU is doing a good job of addressing a difficult problem in orthopedics – especially in the field of trauma.

He said in an interview: “Managing narcotics postoperatively can be challenging due to the fact that many people come into these fractures with a history of narcotic use.” Not only are they used to turning to opioids for pain relief, but they also may have built up a tolerance to them.

Although he hasn’t been using the lopioid protocol specifically, he has been following a multimodal approach regarding the postoperative use of narcotics. Of the study by Dr. Egol and colleagues, he said, “I think their paper presents an effective way of decreasing use of oral narcotics and still adequately managing patients’ pain postoperatively.” Dr. Orton’s own practice utilizes tramadol, acetaminophen, and ibuprofen after fracture surgery.

From Dr. Orton’s perspective, a significant challenge in implementing the lopioid protocol in practice is simply sticking to the plan. “It can become difficult when patients are pressuring staff or physicians for more narcotics. However, I feel that if everybody is on the same page with the plan, then it can be very doable.”

Dr. Egol and NYU try to limit narcotic prescriptions beginning with the patient’s initial visit to the ED. The ED physicians at his institution only “prescribe small amounts of narcotics. Our ED people really limit the amount of opioids prescribed.”

Dr. Egol recommends that all practitioners begin with nonnarcotic medication, even if treating a fracture nonoperatively. “Start low and go higher. I always try to start with NSAIDs and Tylenol,” he said.

Dr. Egol and Dr. Orton reported no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

Orthopedic researchers from New York University have proposed standardizing prescribing patterns for patients after fracture surgery so as to include low-dose opioids.

In a paper presented at the annual meeting of the American Academy of Orthopaedic Surgeons, researchers from NYU reported on the implementation of their multimodal strategy, dubbed the “lopioid protocol.”

According to the 2019 National Survey on Drug Use and Health, orthopedic surgeons are the third-highest opioid prescribers in the United States.

Kennneth A. Egol, MD, vice chair of the department of orthopedic surgery at NYU, who is the first author of the study, was motivated to help create the protocol following misconceptions that orthopedic surgeons were helping to fuel the opioid epidemic.

Dr. Egol pointed to the year 1995, when pain became the fifth vital sign after body temperature, pulse rate, respiratory rate, and blood pressure.

Since then, in light of the opioid epidemic, the focus of physicians has shifted away from prescribing strong pain medication and reducing pain scores to zero to instead reducing pain to a manageable level.

Reducing opioid prescriptions can be challenging when patients are prescribed an anti-inflammatory and they subsequently ask their physician for a “pain pill.” Patients sometimes don’t understand that inflammation is what causes pain.

It can also be difficult to convince patients that medications that they can buy over the counter can adequately control their pain, as confirmed in numerous studies.

Multimodal pain therapy aims to reduce the need for opioids by supplementing their use with other oral medications and, at times, long-lasting regional nerve blocks.

Anti-inflammatories act at the site of injury or surgery where inflammation is occurring. Nerves then carry the pain signal to the brain. These signals can be dampened by medications such as gabapentin that act on the nerves themselves. The pain signal is received in the brain, where opioids act by binding to receptors in the brain.

The so-called lopioid protocol does not eliminate opioids completely but rather uses “safer” opioids, such as tramadol, in lieu of stronger narcotics.

The protocol began at NYU on Jan. 1, 2019. It consists in the prescribing of tramadol, meloxicam, gabapentin, and acetaminophen.

The study presented at the AAOS meeting demonstrated statistically significant reductions in visual analogue pain scores at discharge and subsequent medication refills for the 931 patients in the lopioid group, compared with a group of 848 patients who received narcotic prescriptions containing oxycodone from the year prior to the protocol initiation.

Educating patients on the rationale for the prescription combination can help to allay their fears. Dr. Egol thinks it’s important for physicians to explain the dangers of opioids to patients. He said in an interview that he also believes surgeons need to “give [patients] an understanding of why we are pursuing these protocols. They also need to know we will not ignore their pain and concerns.”

Brannon Orton, MD, is an orthopedic surgeon at Confluence Health, in Moses Lake, Wash. He sees a large number of trauma patients and thinks NYU is doing a good job of addressing a difficult problem in orthopedics – especially in the field of trauma.

He said in an interview: “Managing narcotics postoperatively can be challenging due to the fact that many people come into these fractures with a history of narcotic use.” Not only are they used to turning to opioids for pain relief, but they also may have built up a tolerance to them.

Although he hasn’t been using the lopioid protocol specifically, he has been following a multimodal approach regarding the postoperative use of narcotics. Of the study by Dr. Egol and colleagues, he said, “I think their paper presents an effective way of decreasing use of oral narcotics and still adequately managing patients’ pain postoperatively.” Dr. Orton’s own practice utilizes tramadol, acetaminophen, and ibuprofen after fracture surgery.

From Dr. Orton’s perspective, a significant challenge in implementing the lopioid protocol in practice is simply sticking to the plan. “It can become difficult when patients are pressuring staff or physicians for more narcotics. However, I feel that if everybody is on the same page with the plan, then it can be very doable.”

Dr. Egol and NYU try to limit narcotic prescriptions beginning with the patient’s initial visit to the ED. The ED physicians at his institution only “prescribe small amounts of narcotics. Our ED people really limit the amount of opioids prescribed.”

Dr. Egol recommends that all practitioners begin with nonnarcotic medication, even if treating a fracture nonoperatively. “Start low and go higher. I always try to start with NSAIDs and Tylenol,” he said.

Dr. Egol and Dr. Orton reported no relevant financial disclosures.

A version of this article first appeared on Medscape.com.

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High tibial osteotomy achieves sustained improvements in knee OA

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Fri, 05/14/2021 - 09:23

A study of long-term outcomes after medial opening wedge high tibial osteotomy for knee osteoarthritis suggests the procedure is associated with significant and sustained improvements in pain, function, quality of life, and gait biomechanics.

At the OARSI 2021 World Congress, PhD candidate Codie Primeau, MSc, of the Fowler Kennedy Sport Medicine Clinic at the University of Western Ontario, London, presented the findings from a 10-year prospective cohort study of 102 patients with symptomatic medial compartment knee osteoarthritis who underwent medial opening wedge high tibial osteotomy but did not get a total knee replacement during the study.

The surgical procedure aims to correct malalignment by redistributing knee joint loads away from the affected compartment of the knee, with the ultimate goal of slowing disease progression and improving pain and function, Mr. Primeau told the conference, which was sponsored by the Osteoarthritis Research Society International.

At 10 years, the procedure was associated with a mean 14.3-point improvement in the 0-100 Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, a mean 12-point improvement in the score for function in daily living, a 15.5-point improvement in the score for function in sport and recreation, and a 24.5-point improvement in knee-related quality of life score. Researchers also saw a 35%-45% reduction in the magnitude of the external knee adduction moment from baseline, and a gradual reduction in the knee flexion moment over the course of the study.



While the improvements did decline somewhat over the 10 years, 53% of patients still met the criteria for responder at the end of the follow-up period, meaning that they had a relative change of at least 20% in both KOOS pain and function scores, and an absolute change of at least 10 points.

Mr. Primeau noted that the patient population represented those who were the best candidates for high tibial osteotomy, in that they were keen to avoid total knee replacement.

“While these types of patients may have the best outcomes, our studies suggest patients traditionally not considered ideal candidates for HTO [high tibial osteotomy] – such as females, and patients with limited disease in other knee compartments – also have large improvements in pain and function after HTO, and around 70% of those patients do not get a total knee replacement within 10 years,” he said in an interview.

Mr. Primeau suggested that the improvements achieved with high tibial osteotomy might extend the time before a knee replacement is required, or even help some patients avoid it altogether.

“Importantly, recent studies show HTO does not complicate future joint replacement surgery,” he said. “One can get a knee replacement after HTO; the reverse is not possible.”

The ideal patient for a high tibial osteotomy would be one whose osteoarthritis was confined to the medial compartment of the knee, was younger – in their 40s or 50s – and with relatively high activity levels, he said. Some studies also suggest better outcomes in men than women.



In response to an audience question about the rehabilitation requirements after high tibial osteotomy, Mr. Primeau commented that the design of the plates used in the procedure have changed over time, and this has influenced rehabilitation needs. When the study began, patients needed anywhere from 8 to 12 weeks of no weight bearing, using crutches, to allow for bone consolidation to occur.

“Since then, plate designs have changed a lot, and patients are able to start ambulating as early as 2 weeks after the surgery now,” he said. The rehabilitation is similar to what is required for knee osteoarthritis in general, focusing on range of motion, strengthening, proprioception, and muscle training.

No conflicts of interest were declared.

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A study of long-term outcomes after medial opening wedge high tibial osteotomy for knee osteoarthritis suggests the procedure is associated with significant and sustained improvements in pain, function, quality of life, and gait biomechanics.

At the OARSI 2021 World Congress, PhD candidate Codie Primeau, MSc, of the Fowler Kennedy Sport Medicine Clinic at the University of Western Ontario, London, presented the findings from a 10-year prospective cohort study of 102 patients with symptomatic medial compartment knee osteoarthritis who underwent medial opening wedge high tibial osteotomy but did not get a total knee replacement during the study.

The surgical procedure aims to correct malalignment by redistributing knee joint loads away from the affected compartment of the knee, with the ultimate goal of slowing disease progression and improving pain and function, Mr. Primeau told the conference, which was sponsored by the Osteoarthritis Research Society International.

At 10 years, the procedure was associated with a mean 14.3-point improvement in the 0-100 Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, a mean 12-point improvement in the score for function in daily living, a 15.5-point improvement in the score for function in sport and recreation, and a 24.5-point improvement in knee-related quality of life score. Researchers also saw a 35%-45% reduction in the magnitude of the external knee adduction moment from baseline, and a gradual reduction in the knee flexion moment over the course of the study.



While the improvements did decline somewhat over the 10 years, 53% of patients still met the criteria for responder at the end of the follow-up period, meaning that they had a relative change of at least 20% in both KOOS pain and function scores, and an absolute change of at least 10 points.

Mr. Primeau noted that the patient population represented those who were the best candidates for high tibial osteotomy, in that they were keen to avoid total knee replacement.

“While these types of patients may have the best outcomes, our studies suggest patients traditionally not considered ideal candidates for HTO [high tibial osteotomy] – such as females, and patients with limited disease in other knee compartments – also have large improvements in pain and function after HTO, and around 70% of those patients do not get a total knee replacement within 10 years,” he said in an interview.

Mr. Primeau suggested that the improvements achieved with high tibial osteotomy might extend the time before a knee replacement is required, or even help some patients avoid it altogether.

“Importantly, recent studies show HTO does not complicate future joint replacement surgery,” he said. “One can get a knee replacement after HTO; the reverse is not possible.”

The ideal patient for a high tibial osteotomy would be one whose osteoarthritis was confined to the medial compartment of the knee, was younger – in their 40s or 50s – and with relatively high activity levels, he said. Some studies also suggest better outcomes in men than women.



In response to an audience question about the rehabilitation requirements after high tibial osteotomy, Mr. Primeau commented that the design of the plates used in the procedure have changed over time, and this has influenced rehabilitation needs. When the study began, patients needed anywhere from 8 to 12 weeks of no weight bearing, using crutches, to allow for bone consolidation to occur.

“Since then, plate designs have changed a lot, and patients are able to start ambulating as early as 2 weeks after the surgery now,” he said. The rehabilitation is similar to what is required for knee osteoarthritis in general, focusing on range of motion, strengthening, proprioception, and muscle training.

No conflicts of interest were declared.

A study of long-term outcomes after medial opening wedge high tibial osteotomy for knee osteoarthritis suggests the procedure is associated with significant and sustained improvements in pain, function, quality of life, and gait biomechanics.

At the OARSI 2021 World Congress, PhD candidate Codie Primeau, MSc, of the Fowler Kennedy Sport Medicine Clinic at the University of Western Ontario, London, presented the findings from a 10-year prospective cohort study of 102 patients with symptomatic medial compartment knee osteoarthritis who underwent medial opening wedge high tibial osteotomy but did not get a total knee replacement during the study.

The surgical procedure aims to correct malalignment by redistributing knee joint loads away from the affected compartment of the knee, with the ultimate goal of slowing disease progression and improving pain and function, Mr. Primeau told the conference, which was sponsored by the Osteoarthritis Research Society International.

At 10 years, the procedure was associated with a mean 14.3-point improvement in the 0-100 Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain, a mean 12-point improvement in the score for function in daily living, a 15.5-point improvement in the score for function in sport and recreation, and a 24.5-point improvement in knee-related quality of life score. Researchers also saw a 35%-45% reduction in the magnitude of the external knee adduction moment from baseline, and a gradual reduction in the knee flexion moment over the course of the study.



While the improvements did decline somewhat over the 10 years, 53% of patients still met the criteria for responder at the end of the follow-up period, meaning that they had a relative change of at least 20% in both KOOS pain and function scores, and an absolute change of at least 10 points.

Mr. Primeau noted that the patient population represented those who were the best candidates for high tibial osteotomy, in that they were keen to avoid total knee replacement.

“While these types of patients may have the best outcomes, our studies suggest patients traditionally not considered ideal candidates for HTO [high tibial osteotomy] – such as females, and patients with limited disease in other knee compartments – also have large improvements in pain and function after HTO, and around 70% of those patients do not get a total knee replacement within 10 years,” he said in an interview.

Mr. Primeau suggested that the improvements achieved with high tibial osteotomy might extend the time before a knee replacement is required, or even help some patients avoid it altogether.

“Importantly, recent studies show HTO does not complicate future joint replacement surgery,” he said. “One can get a knee replacement after HTO; the reverse is not possible.”

The ideal patient for a high tibial osteotomy would be one whose osteoarthritis was confined to the medial compartment of the knee, was younger – in their 40s or 50s – and with relatively high activity levels, he said. Some studies also suggest better outcomes in men than women.



In response to an audience question about the rehabilitation requirements after high tibial osteotomy, Mr. Primeau commented that the design of the plates used in the procedure have changed over time, and this has influenced rehabilitation needs. When the study began, patients needed anywhere from 8 to 12 weeks of no weight bearing, using crutches, to allow for bone consolidation to occur.

“Since then, plate designs have changed a lot, and patients are able to start ambulating as early as 2 weeks after the surgery now,” he said. The rehabilitation is similar to what is required for knee osteoarthritis in general, focusing on range of motion, strengthening, proprioception, and muscle training.

No conflicts of interest were declared.

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Intramuscular glucocorticoid injections seen as noninferior to intra-articular in knee OA

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Intramuscular injections of glucocorticoids have efficacy similar to that of intra-articular injections in reducing pain in knee osteoarthritis but without the concerns about joint infection and the challenges of administration, according to results from a randomized, controlled trial reported at the OARSI 2021 World Congress.

Intra-articular injections of glucocorticoids are commonly used to relieve OA pain, but some general practitioners have difficulty administering them to patients, said Qiuke Wang, a PhD candidate at Erasmus University Medical Center in Rotterdam, the Netherlands. There are also concerns about whether intra-articular injections may cause damage to knee cartilage, Mr. Wang said at the conference, which is sponsored by the Osteoarthritis Research Society International.

Mr. Wang and colleagues conducted a randomized, controlled trial in which 145 patients with symptomatic knee OA received either an intramuscular or intra-articular injection of 40 mg triamcinolone acetonide, and then followed up at regular intervals for 24 weeks.



The study showed that Knee Injury and Osteoarthritis Outcome Scores for pain improved in both the intra-articular and intramuscular groups. Improvements in pain scores peaked in the intra-articular injection group at the 4-week mark, when the difference with intramuscular injections was statistically significant. However, the two groups showed no significant differences in pain improvement at the 8-, 12-, and 24-week follow-up points.

“Intra-articular injection can act immediately on inhibiting joint inflammation after injection,” Mr. Wang said in an interview. “In contrast, for intramuscular injection, glucocorticoid needs firstly to be absorbed by muscle into blood and then travel into the knee via the circulatory system.”

The study also showed no significant differences between the two groups in the secondary outcomes of patient symptoms, stiffness, function, and sport and quality of life scores. There were more adverse events in the intra-articular injection group: 42% of patients reported an adverse event, compared to 33% in the intramuscular group, and the adverse events reported in the intramuscular group were nonserious events, such as headache and flushing.

Mr. Wang told the conference that while the intramuscular injection was inferior to intra-articular injections at 4 weeks, it was noninferior at 8 and 24 weeks and should be considered an effective way to reduce pain in patients with knee OA.

“This trial provides evidence for shared decision making because in some cases a patient may have a preference for specific injection and the GP may feel incompetent to administer the intra-articular injection,” he said.

An audience member pointed out that there was now a growing body of evidence suggesting that intra-articular injections may contribute to faster progression of knee OA because of effects on knee cartilage.

Mr. Wang acknowledged that their own research had shown these side effects of intra-articular injections, which was why the trial was intended to examine whether intramuscular injections might achieve the same pain relief.



“In the real practice, I would say that both injections are effective, but the intra-articular injection may provide a slightly [better] effect in the short term,” he said.

Commenting on the findings, Martin van der Esch, PhD, of Amsterdam University of Applied Sciences, said there were no guidelines as to whether intra-articular or intramuscular injections were the best option, so it really came down to the clinician’s decision.

“Therefore this is really an interesting study, because it gives some light – not the answer – but some light in what direction it could go for specific groups of patients,” Dr. van der Esch said in an interview.

Dr. van der Esch suggested that intramuscular injections might be more appropriate for patients with more systemic disease affecting multiple joints, but intra-articular injections might offer greater benefits in a patient with severe and long-lasting disease in a single joint.

No conflicts of interest were declared.

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Intramuscular injections of glucocorticoids have efficacy similar to that of intra-articular injections in reducing pain in knee osteoarthritis but without the concerns about joint infection and the challenges of administration, according to results from a randomized, controlled trial reported at the OARSI 2021 World Congress.

Intra-articular injections of glucocorticoids are commonly used to relieve OA pain, but some general practitioners have difficulty administering them to patients, said Qiuke Wang, a PhD candidate at Erasmus University Medical Center in Rotterdam, the Netherlands. There are also concerns about whether intra-articular injections may cause damage to knee cartilage, Mr. Wang said at the conference, which is sponsored by the Osteoarthritis Research Society International.

Mr. Wang and colleagues conducted a randomized, controlled trial in which 145 patients with symptomatic knee OA received either an intramuscular or intra-articular injection of 40 mg triamcinolone acetonide, and then followed up at regular intervals for 24 weeks.



The study showed that Knee Injury and Osteoarthritis Outcome Scores for pain improved in both the intra-articular and intramuscular groups. Improvements in pain scores peaked in the intra-articular injection group at the 4-week mark, when the difference with intramuscular injections was statistically significant. However, the two groups showed no significant differences in pain improvement at the 8-, 12-, and 24-week follow-up points.

“Intra-articular injection can act immediately on inhibiting joint inflammation after injection,” Mr. Wang said in an interview. “In contrast, for intramuscular injection, glucocorticoid needs firstly to be absorbed by muscle into blood and then travel into the knee via the circulatory system.”

The study also showed no significant differences between the two groups in the secondary outcomes of patient symptoms, stiffness, function, and sport and quality of life scores. There were more adverse events in the intra-articular injection group: 42% of patients reported an adverse event, compared to 33% in the intramuscular group, and the adverse events reported in the intramuscular group were nonserious events, such as headache and flushing.

Mr. Wang told the conference that while the intramuscular injection was inferior to intra-articular injections at 4 weeks, it was noninferior at 8 and 24 weeks and should be considered an effective way to reduce pain in patients with knee OA.

“This trial provides evidence for shared decision making because in some cases a patient may have a preference for specific injection and the GP may feel incompetent to administer the intra-articular injection,” he said.

An audience member pointed out that there was now a growing body of evidence suggesting that intra-articular injections may contribute to faster progression of knee OA because of effects on knee cartilage.

Mr. Wang acknowledged that their own research had shown these side effects of intra-articular injections, which was why the trial was intended to examine whether intramuscular injections might achieve the same pain relief.



“In the real practice, I would say that both injections are effective, but the intra-articular injection may provide a slightly [better] effect in the short term,” he said.

Commenting on the findings, Martin van der Esch, PhD, of Amsterdam University of Applied Sciences, said there were no guidelines as to whether intra-articular or intramuscular injections were the best option, so it really came down to the clinician’s decision.

“Therefore this is really an interesting study, because it gives some light – not the answer – but some light in what direction it could go for specific groups of patients,” Dr. van der Esch said in an interview.

Dr. van der Esch suggested that intramuscular injections might be more appropriate for patients with more systemic disease affecting multiple joints, but intra-articular injections might offer greater benefits in a patient with severe and long-lasting disease in a single joint.

No conflicts of interest were declared.

Intramuscular injections of glucocorticoids have efficacy similar to that of intra-articular injections in reducing pain in knee osteoarthritis but without the concerns about joint infection and the challenges of administration, according to results from a randomized, controlled trial reported at the OARSI 2021 World Congress.

Intra-articular injections of glucocorticoids are commonly used to relieve OA pain, but some general practitioners have difficulty administering them to patients, said Qiuke Wang, a PhD candidate at Erasmus University Medical Center in Rotterdam, the Netherlands. There are also concerns about whether intra-articular injections may cause damage to knee cartilage, Mr. Wang said at the conference, which is sponsored by the Osteoarthritis Research Society International.

Mr. Wang and colleagues conducted a randomized, controlled trial in which 145 patients with symptomatic knee OA received either an intramuscular or intra-articular injection of 40 mg triamcinolone acetonide, and then followed up at regular intervals for 24 weeks.



The study showed that Knee Injury and Osteoarthritis Outcome Scores for pain improved in both the intra-articular and intramuscular groups. Improvements in pain scores peaked in the intra-articular injection group at the 4-week mark, when the difference with intramuscular injections was statistically significant. However, the two groups showed no significant differences in pain improvement at the 8-, 12-, and 24-week follow-up points.

“Intra-articular injection can act immediately on inhibiting joint inflammation after injection,” Mr. Wang said in an interview. “In contrast, for intramuscular injection, glucocorticoid needs firstly to be absorbed by muscle into blood and then travel into the knee via the circulatory system.”

The study also showed no significant differences between the two groups in the secondary outcomes of patient symptoms, stiffness, function, and sport and quality of life scores. There were more adverse events in the intra-articular injection group: 42% of patients reported an adverse event, compared to 33% in the intramuscular group, and the adverse events reported in the intramuscular group were nonserious events, such as headache and flushing.

Mr. Wang told the conference that while the intramuscular injection was inferior to intra-articular injections at 4 weeks, it was noninferior at 8 and 24 weeks and should be considered an effective way to reduce pain in patients with knee OA.

“This trial provides evidence for shared decision making because in some cases a patient may have a preference for specific injection and the GP may feel incompetent to administer the intra-articular injection,” he said.

An audience member pointed out that there was now a growing body of evidence suggesting that intra-articular injections may contribute to faster progression of knee OA because of effects on knee cartilage.

Mr. Wang acknowledged that their own research had shown these side effects of intra-articular injections, which was why the trial was intended to examine whether intramuscular injections might achieve the same pain relief.



“In the real practice, I would say that both injections are effective, but the intra-articular injection may provide a slightly [better] effect in the short term,” he said.

Commenting on the findings, Martin van der Esch, PhD, of Amsterdam University of Applied Sciences, said there were no guidelines as to whether intra-articular or intramuscular injections were the best option, so it really came down to the clinician’s decision.

“Therefore this is really an interesting study, because it gives some light – not the answer – but some light in what direction it could go for specific groups of patients,” Dr. van der Esch said in an interview.

Dr. van der Esch suggested that intramuscular injections might be more appropriate for patients with more systemic disease affecting multiple joints, but intra-articular injections might offer greater benefits in a patient with severe and long-lasting disease in a single joint.

No conflicts of interest were declared.

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Weight cycling linked to cartilage degeneration in knee OA

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Wed, 05/05/2021 - 10:39

Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.

©pixologicstudio/Thinkstock
knee_pain

A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m2 or above, which examined the effects of “weight cycling” on OA outcomes.

Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.

The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.

Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.

However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.

Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.



“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.

Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.

While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.

“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”

She suggested both these possibilities could be explored in future studies of weight cycling and its effects.

“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

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Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.

©pixologicstudio/Thinkstock
knee_pain

A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m2 or above, which examined the effects of “weight cycling” on OA outcomes.

Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.

The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.

Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.

However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.

Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.



“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.

Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.

While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.

“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”

She suggested both these possibilities could be explored in future studies of weight cycling and its effects.

“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

Repetitive weight loss and gain in overweight or obese patients with knee osteoarthritis is associated with significantly greater cartilage and bone marrow edema degeneration than stable weight or steady weight loss, research suggests.

©pixologicstudio/Thinkstock
knee_pain

A presentation at the OARSI 2021 World Congress outlined the results of a study using Osteoarthritis Initiative data from 2,271 individuals with knee osteoarthritis and a body mass index (BMI) of 25 kg/m2 or above, which examined the effects of “weight cycling” on OA outcomes.

Gabby Joseph, PhD, of the University of California, San Francisco, told the conference – which was sponsored by the Osteoarthritis Research Society International – that previous studies had shown weight loss improves OA symptoms and slow progression, and weight gain increases OA risk. However no studies had yet examined the effects of weight cycling.

The study compared 4 years of MRI data for those who showed less than 3% loss or gain in weight over that time – the control group – versus those who lost more than 5% over that time and those who gained more than 5%. Among these were 249 individuals in the top 10% of annual weight change over that period, who were designated as weight cyclers. They tended to be younger, female, and with slightly higher average BMI than noncyclers.

Weight cyclers had significantly greater progression of cartilage degeneration and bone marrow edema degeneration – as measured by whole-organ magnetic resonance score – than did noncyclers, regardless of their overall weight gain or loss by the end of the study period.

However, the study did not see any significant differences in meniscus progression between cyclers and noncyclers, and cartilage thickness decreased in all groups over the 4 years with no significant effects associated with weight gain, loss, or cycling. Dr. Joseph commented that future studies could use voxel-based relaxometry to more closely study localized cartilage abnormalities.

Researchers also examined the effect of weight cycling on changes to walking speed, and found weight cyclers had significantly lower walking speeds by the end of the 4 years, regardless of overall weight change.



“What we’ve seen is that fluctuations are not beneficial for your joints,” Dr. Joseph told the conference. “When we advise patients that they want to lose weight, we want to do this in a very steady fashion; we don’t want yo-yo dieting.” She gave the example of one patient who started the study with a BMI of 36, went up to 40 then went down to 32.

Commenting on the study, Lisa Carlesso, PhD, of McMaster University, Hamilton, Ont., said it addresses an important issue because weight cycling is common as people struggle to maintain weight loss.

While it is difficult to speculate on the physiological mechanisms that might explain the effect, Dr. Carlesso noted that there were significantly more women than men among the weight cyclers.

“We know, for example, that obese women with knee OA have significantly higher levels of the adipokine leptin, compared to men, and leptin is involved in cartilage degeneration,” Dr. Carlesso said. “Similarly, we don’t have any information about joint alignment or measures of joint load, two things that could factor into the structural changes found.”

She suggested both these possibilities could be explored in future studies of weight cycling and its effects.

“It has opened up new lines of inquiry to be examined to mechanistically explain the relationship between cycling and worse cartilage and bone marrow degeneration,” Dr. Carlesso said.

The study was supported by the National Institutes of Health. No conflicts of interest were declared.

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COVID-19 vaccination in RMD patients: Safety data “reassuring”

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Tue, 02/07/2023 - 16:47

Two reports support the safety and immunogenicity of SARS-CoV-2 mRNA vaccines in patients with rheumatic and musculoskeletal diseases (RMDs) and represent the first available data on such patients.

peterschreiber_media/iStock/Getty Images

In an observational cohort study published in Annals of the Rheumatic Diseases, Caoilfhionn M. Connolly, MD, of Johns Hopkins University, Baltimore, and colleagues reviewed data from 325 adults with RMDs who received the first dose of SARS-CoV-2 mRNA vaccine during the period of Dec. 17, 2020, to Feb. 11, 2021. Of these, 51% received the Pfizer/BioNTech vaccine and 49% received the Moderna vaccine.

The patients, who were invited to participate on social media, were aged 34-54 years, 96% were women, and 89% were White. Inflammatory arthritis was the most common RMD condition (38%), followed by systemic lupus erythematosus (28%) and overlap connective tissue disease (19%). The patients were using a range of immunomodulatory treatment regimens, including nonbiologic disease modifying antirheumatic drugs (DMARDs) in 44%, biologics in 19%, and combination therapy in 37%.



Overall, 89% of patients reported localized symptoms of pain, swelling, and erythema, and 69% reported systemic symptoms. Fatigue was the most common systemic symptom, and 7.4% reported severe fatigue.

None of the patients experienced allergic reactions requiring epinephrine, and 3% reported new infections that required treatment.

“These early, reassuring results may ameliorate concern among patients and provide guidance for rheumatology providers in critical discussions regarding vaccine hesitancy or refusal,” they concluded.

Antibody responses

In another study published in Annals of the Rheumatic Diseases by the same group of researchers, antibody responses against the receptor binding domain of the SARS-CoV-2 spike protein were seen in 74% of 123 adults with an RMD at 18-26 days after receiving a first dose of SARS-CoV-2 mRNA vaccine (52% Pfizer vaccine and 48% Moderna) between Jan. 8, 2021, and Feb. 12, 2021.

The most common diagnoses in these patients were inflammatory arthritis (28%), systemic lupus erythematosus (20%), and Sjögren’s syndrome (13%). A total of 28% of participants reported taking no immunomodulatory agents, 19% reported nonbiologic DMARDs, 14% reported biologic DMARDs, and 19% reported combination therapy.

Although no differences appeared based on disease groups or overall categories of immunomodulatory therapies, patients whose treatment included mycophenolate or rituximab were significantly less likely to develop antibody responses than were patients not taking these medications (P = .001 and P = .04, respectively). Although rituximab and methotrexate have been associated with reduced responses to vaccines such as the flu vaccine, methotrexate was not associated with reduced vaccine response in this study. A total of 94% of patients taking a tumor necrosis factor inhibitor had detectable antibodies.



The studies’ findings were limited by several factors including a lack of longer-term safety data; the small, nonrandomized sample of mainly white women; limited information on immunomodulatory drug dosage and timing; lack of serial antibody measurements; use of an enzyme immunoassay designed to detect antibody response after natural infection; and the inclusion of data only on the first dose of a two-dose vaccine series, the researchers noted. However, the data should provide additional reassurance to RMD patients and their health care teams about vaccination against COVID-19, they said.

Both studies were supported by the Ben-Dov family. In addition, the studies were supported by grants to various study authors from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Transplantation and Immunology Research Network of the American Society of Transplantation. One author disclosed financial relationships with Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. The other researchers had no financial conflicts to disclose.

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Two reports support the safety and immunogenicity of SARS-CoV-2 mRNA vaccines in patients with rheumatic and musculoskeletal diseases (RMDs) and represent the first available data on such patients.

peterschreiber_media/iStock/Getty Images

In an observational cohort study published in Annals of the Rheumatic Diseases, Caoilfhionn M. Connolly, MD, of Johns Hopkins University, Baltimore, and colleagues reviewed data from 325 adults with RMDs who received the first dose of SARS-CoV-2 mRNA vaccine during the period of Dec. 17, 2020, to Feb. 11, 2021. Of these, 51% received the Pfizer/BioNTech vaccine and 49% received the Moderna vaccine.

The patients, who were invited to participate on social media, were aged 34-54 years, 96% were women, and 89% were White. Inflammatory arthritis was the most common RMD condition (38%), followed by systemic lupus erythematosus (28%) and overlap connective tissue disease (19%). The patients were using a range of immunomodulatory treatment regimens, including nonbiologic disease modifying antirheumatic drugs (DMARDs) in 44%, biologics in 19%, and combination therapy in 37%.



Overall, 89% of patients reported localized symptoms of pain, swelling, and erythema, and 69% reported systemic symptoms. Fatigue was the most common systemic symptom, and 7.4% reported severe fatigue.

None of the patients experienced allergic reactions requiring epinephrine, and 3% reported new infections that required treatment.

“These early, reassuring results may ameliorate concern among patients and provide guidance for rheumatology providers in critical discussions regarding vaccine hesitancy or refusal,” they concluded.

Antibody responses

In another study published in Annals of the Rheumatic Diseases by the same group of researchers, antibody responses against the receptor binding domain of the SARS-CoV-2 spike protein were seen in 74% of 123 adults with an RMD at 18-26 days after receiving a first dose of SARS-CoV-2 mRNA vaccine (52% Pfizer vaccine and 48% Moderna) between Jan. 8, 2021, and Feb. 12, 2021.

The most common diagnoses in these patients were inflammatory arthritis (28%), systemic lupus erythematosus (20%), and Sjögren’s syndrome (13%). A total of 28% of participants reported taking no immunomodulatory agents, 19% reported nonbiologic DMARDs, 14% reported biologic DMARDs, and 19% reported combination therapy.

Although no differences appeared based on disease groups or overall categories of immunomodulatory therapies, patients whose treatment included mycophenolate or rituximab were significantly less likely to develop antibody responses than were patients not taking these medications (P = .001 and P = .04, respectively). Although rituximab and methotrexate have been associated with reduced responses to vaccines such as the flu vaccine, methotrexate was not associated with reduced vaccine response in this study. A total of 94% of patients taking a tumor necrosis factor inhibitor had detectable antibodies.



The studies’ findings were limited by several factors including a lack of longer-term safety data; the small, nonrandomized sample of mainly white women; limited information on immunomodulatory drug dosage and timing; lack of serial antibody measurements; use of an enzyme immunoassay designed to detect antibody response after natural infection; and the inclusion of data only on the first dose of a two-dose vaccine series, the researchers noted. However, the data should provide additional reassurance to RMD patients and their health care teams about vaccination against COVID-19, they said.

Both studies were supported by the Ben-Dov family. In addition, the studies were supported by grants to various study authors from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Transplantation and Immunology Research Network of the American Society of Transplantation. One author disclosed financial relationships with Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. The other researchers had no financial conflicts to disclose.

Two reports support the safety and immunogenicity of SARS-CoV-2 mRNA vaccines in patients with rheumatic and musculoskeletal diseases (RMDs) and represent the first available data on such patients.

peterschreiber_media/iStock/Getty Images

In an observational cohort study published in Annals of the Rheumatic Diseases, Caoilfhionn M. Connolly, MD, of Johns Hopkins University, Baltimore, and colleagues reviewed data from 325 adults with RMDs who received the first dose of SARS-CoV-2 mRNA vaccine during the period of Dec. 17, 2020, to Feb. 11, 2021. Of these, 51% received the Pfizer/BioNTech vaccine and 49% received the Moderna vaccine.

The patients, who were invited to participate on social media, were aged 34-54 years, 96% were women, and 89% were White. Inflammatory arthritis was the most common RMD condition (38%), followed by systemic lupus erythematosus (28%) and overlap connective tissue disease (19%). The patients were using a range of immunomodulatory treatment regimens, including nonbiologic disease modifying antirheumatic drugs (DMARDs) in 44%, biologics in 19%, and combination therapy in 37%.



Overall, 89% of patients reported localized symptoms of pain, swelling, and erythema, and 69% reported systemic symptoms. Fatigue was the most common systemic symptom, and 7.4% reported severe fatigue.

None of the patients experienced allergic reactions requiring epinephrine, and 3% reported new infections that required treatment.

“These early, reassuring results may ameliorate concern among patients and provide guidance for rheumatology providers in critical discussions regarding vaccine hesitancy or refusal,” they concluded.

Antibody responses

In another study published in Annals of the Rheumatic Diseases by the same group of researchers, antibody responses against the receptor binding domain of the SARS-CoV-2 spike protein were seen in 74% of 123 adults with an RMD at 18-26 days after receiving a first dose of SARS-CoV-2 mRNA vaccine (52% Pfizer vaccine and 48% Moderna) between Jan. 8, 2021, and Feb. 12, 2021.

The most common diagnoses in these patients were inflammatory arthritis (28%), systemic lupus erythematosus (20%), and Sjögren’s syndrome (13%). A total of 28% of participants reported taking no immunomodulatory agents, 19% reported nonbiologic DMARDs, 14% reported biologic DMARDs, and 19% reported combination therapy.

Although no differences appeared based on disease groups or overall categories of immunomodulatory therapies, patients whose treatment included mycophenolate or rituximab were significantly less likely to develop antibody responses than were patients not taking these medications (P = .001 and P = .04, respectively). Although rituximab and methotrexate have been associated with reduced responses to vaccines such as the flu vaccine, methotrexate was not associated with reduced vaccine response in this study. A total of 94% of patients taking a tumor necrosis factor inhibitor had detectable antibodies.



The studies’ findings were limited by several factors including a lack of longer-term safety data; the small, nonrandomized sample of mainly white women; limited information on immunomodulatory drug dosage and timing; lack of serial antibody measurements; use of an enzyme immunoassay designed to detect antibody response after natural infection; and the inclusion of data only on the first dose of a two-dose vaccine series, the researchers noted. However, the data should provide additional reassurance to RMD patients and their health care teams about vaccination against COVID-19, they said.

Both studies were supported by the Ben-Dov family. In addition, the studies were supported by grants to various study authors from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and the Transplantation and Immunology Research Network of the American Society of Transplantation. One author disclosed financial relationships with Sanofi, Novartis, CSL Behring, Jazz Pharmaceuticals, Veloxis, Mallinckrodt, and Thermo Fisher Scientific. The other researchers had no financial conflicts to disclose.

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